Are you preparing to bring your medical device to the U.S. market through the 510(k) regulatory pathway? This guide will walk you through the essential steps to ensure a successful submission.
Key Considerations for 510(k) Submission
Define Your Device’s Marketing Strategy Start by clearly articulating your device’s features, benefits, and intended use. This forms the foundation of your marketing strategy in the U.S.
Select an Appropriate Predicate Device Choose a predicate device that demonstrates substantial equivalence based on your marketing claims, intended use, and technical characteristics. This is crucial for establishing your device’s legitimacy.
Determine the Type of 510(k) Submission Identify whether a traditional, special, or abbreviated 510(k) submission is suitable for your device. Tailor your submission accordingly to meet the specific requirements of each type.
Compile Necessary Tests and Data Gather all required tests and data to support your submission. Utilize recognized consensus standards and adhere to relevant FDA guidance to ensure your documentation is comprehensive.
Advocate for Your 510(k) Submission It’s not enough to simply provide evidentiary documents. Advocate for your submission by clearly presenting the data and demonstrating the safety and efficacy of your device.
Maintain Data Integrity and Good Submission Practices Ensure the integrity of your data by following good submission practices. This facilitates a smoother review process and enhances the credibility of your submission.
Familiarize Yourself with eSTAR Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using eSTAR. Understanding this system is essential for compliance.
Understand MDUFA Metrics Be aware of how the Medical Device User Fee Amendments (MDUFA) metrics impact FDA actions and timelines. This knowledge can help in planning and managing expectations.
Engage with the FDA Utilize available options to communicate with the FDA both before and during your submission process. Establishing a dialogue can clarify requirements and expedite the review process.
Know the Role of the CDRH Deputy Ombudsman Familiarize yourself with the function of the CDRH Deputy Ombudsman. This can be a valuable resource if you encounter challenges during the submission process.
By carefully considering these points, you can enhance the likelihood of a successful 510(k) submission, bringing your medical device to the U.S. market efficiently and effectively.
In this post we would like to highlight the relevance of appropriate computer system classification based on GAMP 5 guidelines. GAMP 5 establishes a framework for validating computerized systems in the healthcare sectors. Computer systems should be properly classified in order to determine the amount of risk associated with a system as well as the controls required to reduce those risks. Those actions dictate the validation effort. GAMP 5 divides computer systems into three categories: 3, 4, and 5. (There is another category for software but it’s for Infrastructure Software, Tools, and IT services)
Here is the definition of the different categories:
Category 3
Off-the-Shelf products used for business purposes, which includes systems that cannot be configured and that are configurable but for which only the default configuration is used.
Category 4
Configurable software products that provide standard interfaces and functions that enable configuration of user specific business or manufacturing processes. This typically involves configuring predefined software modules and possibly developing further customized modules.
Category 5
Customized systems are developed to meet the specific needs of the users. Custom development may be a completely new system or an extension to an existing system. Complex systems often have layers of software, with one system including components of several software categories; these are commonly treated as Category 5.
V shape model Category 3
For example, UV system that runs on all the spectrumand user’s privileges can’t be changed.
V shape model Category 4
For example, UV system that I can billed different protocol with different light spectrums to fit my needs.
V shape model Category 5
For example, a QMS system that connects to a lab system to collect the date from there and when there is a deviation in the test automatically the QMS will open a deviation form.
As we have seen there is an impact for the different categories on the validation that is need to be performed. So, let’s go to the most important question, How do we determine what category, the system we have or the one we want to purchase? In order to do that we will need first to determine whether this system have any impact on cGxP according to the following bullets:
Automation or control any of: Manufacturing, Sterilization, Formulation, Labeling, Inventory, or Critical Environment Controls
System will be an original source of data for the automation or control of any of: Manufacturing, Sterilization, Formulation, Labeling, Inventory, or Critical Environment Controls
System will use raw and in-process material, clinical data analysis, automated inspection equipment and laboratory data system
System is used to generate, manage and analyze data concerning Product Quality, Safety, Efficacy, Strength Stability or identify
Supporting any GxP Functions such as Calibration, Maintenance Scheduling, and Quality Trending
Manage market complaints or adverse event reporting or electronic document submission/reporting to regulatory agencies
Maintaining copies of protocol pertaining to non-clinical study?
If your answer is No then great, we stop the process here. If you have one answer of Yes, so the system is related to cGxP, and we should move to the next set of questions to decide the systems category.
Was the system developed specifically for the company or any customization done to this application?
If your answer is yes then your system is Category 5 If not we will go to the next question
Is the system a standard product developed by a Vendor where the System-Level Configuration is being modified (excluding Run-Time Configuration) to fit the company’s business process/flow?
If your answer is yes then your system is Category 4 If not we will go to the next question
Is the software a standard product developed by a Vendor and is either
not configurable or
configurable but only the default configuration like run time? (Category 3 – Non-Configured)
If this is the correct then your system is Category 3 If You are not sure contact us for further assistance
Most companies have a risk methodology in place. In this post, we want to remind you of the critical questions that should guide you during the risk assessment process and the key points where your computerized system can be at risk. But before the questions, do you need to consider your acceptable risk level? The questions we should have in mind: ▪ What can go wrong? ▪ What is the harm? ▪ What is the impact? ▪ What is the probability of a system failure? ▪ What is the detectability of a failure? ▪ How will the risk be managed? The essential thing is to remember that there are risks during the Computerized system life cycle.
If you recognize a risk in one of your systems in one of the different parts of the life cycle, please don’t hesitate to contact us; we would be happy to help you.
The new In Vitro Diagnostic Regulation (IVDR) 2017/746 is a set of regulations issued by the European Union (EU) for the control and supervision of in vitro diagnostic medical devices (IVDs). These regulations aim to improve the safety and effectiveness of IVDs and ensure that they are of high quality.
The IVDR has been applicable since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 26 May 2025 for high-risk in vitro diagnostics to 26 May 2027 for lower risk in vitro diagnostics, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions.
To be prepared for the IVDR, there are several steps that manufacturers, distributors, and other stakeholders can take: Familiarize yourself with the requirements of the IVDR. Make sure you understand the requirements of the IVDR and how they apply to your organization and products. Verify your device classification according to the IVDR new classification system as you may now require the involvement of a Notified Body. Review your current processes and procedures. Ensure that your processes and procedures for developing, manufacturing, and distributing IVDs comply with the requirements of the IVDR. Develop a plan for transitioning to the IVDR, including timelines and budgets. Consider seeking assistance from a third party, such as a regulatory affairs consultancy, to help you navigate the transition to the IVDR. Keep up to date with developments in the IVDR and any changes or updates to the regulations.
By following these steps, you can ensure that your organization is prepared for the IVDR and can continue to provide high-quality IVDs to patients. Contact US for further support and guidance.
This article was prepared by:
Dr. Einat Dekel, DVM
QA & RA Medical Device Senior Consultant, SME In-Vitro Diagnostics & Digital Health
When discussing upgrading the company’s quality system and technical documentation to meet the EU-MDR requirements, many of the companies still think that this is “an activity that QA&RA department should deal with”.
However, the truth is that the main failure cause or bottleneck for upgrading to EU-MDR is the activity related to design and development. For example, product verification and validation tests that have not been performed, design and development documentation that was not kept up-to-date (specifications, drawings etc.), product risk management plans and reports, design changes that were not analyzed and implemented properly and/or were not followed by the relevant verification and/or validation tests, customer complaints that were not analyzed properly as far as influence on product performance and safety is concerned, clinical evaluation documentation including postmarking clinical follow-up and in some cases also the need for clinical trials.
These activities take time, usually, months or even years. Many of these requirements were already there in the MDD, but they were not enforced by the NBs to the extent that they are enforced under the EU-MDR. If the company does not have significant support from the design and development team, the QA&RA departments will not be able to successfully lead the effort to meet the requirements of the EU-MDR. The issues described in relation to design and development, are also critical for successful FDA inspections, which have significantly increased over the last year. It is very important to recognize this fact and understand what needs to be done to achieve compliance.
If you recognize a risk in one of your systems in one of the different parts of the life cycle, please don’t hesitate to contact us; we would be happy to help you.
A traditional clinical trial is carried out at an investigational site, with all patients traveling to and from sites for receiving the investigational treatment and being examined for safety and efficacy. This traditional approach was restricted due to the covid-19 pandemic, and studies around the world were placed in jeopardy. The traditional format of the clinical trials was challenged and led sponsors to look for advanced solutions to overcome and enable clinical operations continuity. Decentralized clinical trials offer a hybrid approach and include solutions that enable more flexibility to patients, clinical staff, and sponsors alike. So, what are decentralized trials, and what advantages do they bring?
A decentralized clinical trial is a modern evolving approach that includes different levels of integration of technological solutions that enable activities and assessments to be performed virtually such as electronic informed consent, video and telemedicine visits, home health, supply chain extensions, and basic remote monitoring. This approach and solutions enable the improvement of data collection flow, recruitment, and patient compliance.
How and why did DCTs become popular?
A major factor for the increase in popularity of decentralized clinical trials was the COVID-19 pandemic. The nature of the global pandemic forced society to find alternative ways to function, and clinical trials were no different. Although decentralized trials were already operating before the COVID-19 pandemic (Pfizer completed its first decentralized clinical trial in 2011), this type of trial became much more popular in response to the global pandemic.
What are the different types of decentralized trials?
Decentralization can be split into two categories:
Fully remote
A fully remote clinical trial is conducted virtually, using mobile devices, remote monitoring software, and apps. Sometimes, home visits are also offered, or patients are required to travel to labs located near their homes. Fully remote clinical trials take advantage of recent advances in telemedicine, and there is no defined “study site” to speak of.
Hybrid
As the name suggests, hybrid clinical trials combine traditional, on-site clinical trials with remote clinical trials. Some activities are conducted remotely, using the technologies described above, while other activities occur at designated study sites. This model is becoming increasingly popular with study sponsors across a wide range of fields and industries.
What are the advantages of decentralized clinical trials?
Decentralization comes with many advantages, including the following:
●Flexibility. Because the model reduces the need to physically travel to a designated study site, a DCT offers much more flexibility for patients. Using telehealth and wearables, data can be submitted from anywhere, at any time.
●Ease of participation. Reducing the need to travel to a study site makes it much easier for patients to participate in clinical trials. The option to participate remotely reduces a major barrier and allows more participants to enroll in a trial.
●Saves time. Recent research has shown that decentralized phase 2 clinical trials can be completed one to three months faster than traditional trials, with phase 3 trials also saving time compared to their traditional counterparts.
●Better generalizability of trial results. With fewer barriers, more patients can enroll in decentralized trials. This makes it easier for trials to enroll a more diverse patient population, which allows for fewer caveats and greater generalizability of the overall results of the trial.
●Improved patient engagement. Patient engagement is higher, and patients are more likely to participate in a clinical trial for the entire duration if the “patient burden” is reduced. The flexibility of decentralization significantly reduces the patient burden, improving patient engagement.
●Authenticity and reliability of data. Due to the use of technology such as wearables and real-time monitoring devices, decentralized trials often lead to more robust data.
●Improves enrollment potential. Transportation is a major barrier to trial enrollment. With decentralized clinical trials, this barrier is largely removed, which improves the potential patient pool.
● Real-time study overview. Collecting data remotely, and in real-time, means that the study team can identify missing data or deviations that must be addressed immediately. Real-time monitoring is especially advantageous for safety data, as any adverse events can be acted upon immediately.
What are the challenges of decentralized clinical trials?
While decentralization offers several advantages, there are also some challenges associated with this newer trial format, including:
●Infrastructure. Clinical trials require a great deal of infrastructure, including financial support, information systems, technology, staff, and more. Coordinating this remotely, and ensuring that all patients receive and administer medications appropriately is a significant logistical challenge.
●Technological skills needed by participants. DCTs often involve patients administering their medication, or affixing their own wearable devices. This requires patients to have some skills in these areas or risks the integrity of trial data.
●Design and planning. DCTs require comprehensive planning to promise smooth execution. The DCT approach requires interaction and interface of many factors and the process needs to be well planned, validated, and documented
●Data quality. Some decentralized clinical trials rely on self-reported data, which may increase certain forms of bias and not be as accurate as data collected from a traditional trial site.
●Patient safety. Patient safety needs to be carefully considered in DCTs. As patients are often not required to report to a trial site, stringent trial monitoring needs to be in place to ensure that all patients are appropriately and frequently assessed for adverse events.
●Regulations. As patients are given more freedom with a DCT, trial staff must ensure that regulations are adhered to despite the reduced patient contact and interaction.
The future of clinical trials
The technological development landscape and regulatory approach towards DCT enable the integration of advanced solutions to improve main parameters in the execution of clinical trials, in particular aspects of recruitment, duration, and cost. Yet, the full integration of applicable solutions should be considered and built in the early stages of the trial design.
Gsap CRO supports sponsors during the planning phase and clinical trial protocol development to promise appropriate integration of the relevant DCT solutions into their operation. This increases the value to the sponsor, improving data authenticity and reducing patient burden.
Clinical trials with Gsap
Gsap is a boutique Contract Research Organization (CRO) with vast experience across a wide range of industries. Gsap’s full-service CRO services will help ensure your trial runs smoothly from start to finish. Whether you are running a traditional clinical trial, a hybrid trial, or a fully-remote clinical trial, Gsap has the professionals on staff to make it a success.
A boutique CRO offering personalized support
The team at Gsap ensures that you have much more than an organization to plan and execute all facets of your clinical trial. Gsap acts as a partner, providing personalized services based on your trial’s specific needs.
Gsap has helped hundreds of clients execute clinical trials across cell and gene therapy, medical cannabis, medical devices, digital health, and beyond. The Gsap holistic approach to CRO services helps to ensure the success of your clinical trial.
Contact Gsap today to discuss your upcoming clinical trial.
This article was prepared by:
Matti Hoggeg, M.Sc.
Clinical Section Manager
For more information about our CRO services visit:
Contract research organizations (CROs) can be excellent assets for companies in the biotech, pharmaceutical, or medical device industries. But what can a CRO actually bring to your company, and when should you enlist the services of a CRO? Let’s take a look at what a contract research organization is, the services offered by CROs, the benefits of CROs, and how to choose a CRO that meets your clinical study’s needs
In short, a contract research organization (CRO) is a company or business that offers support for clinical studies in the biotech, medical device, or biopharma industries. CROs are experts in clinical trial execution, their experts include different disciplines such as CPMs – Clinical Project Managers, CRAs – Clinical Research Associates, Medical Writers, Data Managers etc., thus they can help companies, businesses, or institutions (usually referred to as trial “sponsors”) reduce the costs and often lengthy timelines associated with a clinical study.
What does a contract research organization do?
Now that we’ve addressed what a CRO is, let’s take a look at what a CRO does. A clinical research organization is hired by a clinical trial sponsor and is then responsible for the planning, management, and execution of the entire clinical trial.
The role of a CRO and its assigned team is to ensure that a clinical trial is performed to the highest standards, according to the guidelines and regulations, to ensure the participant’s safety is maintained and that all data is robust and accurate. At the same time, the clinical research organization is responsible for performing the trial efficiently and as cost-effectively as possible.
What services does a clinical research organization provide?
The CRO acts as the main point of contact and coordinates between the sponsor and other stakeholders in the clinical trial, including regulatory bodies, ethics committees, physicians/medical staff, research coordinators, and vendors.
Specific services typically offered by a clinical research organization include:
● Study planning and design ● Medical writing of study protocol and other core documents ● Study feasibility, start-up, and document preparation ● Site selection and activation ● Regulatory submissions and contracts ● Site management and clinical monitoring ● Data management, data analysis and biostatistics ● Clinical trial Project management ● Interim and final study reports ● Quality assurance (QA) and audits
Contract research organizations (CROs) have the skills and knowledge required to run a successful clinical trial and ensure that all elements of the trial are compliant with local and international requirements.
What are the benefits of a CRO?
There are a lot of advantages associated with a contract research organization. The most important include:
Expertise and experience
Most sponsors looking to undertake a clinical trial do not have experience in all of the areas listed above. Therefore, teaming up with a CRO that has the resources, personnel, and experience needed to execute a successful trial offers a much simpler and more streamlined approach to conducting a clinical trial.
Cost-effectiveness
Another major benefit is cost reduction. A clinical research organization that can keep a clinical trial running according to a pre-determined schedule can save the sponsor significant financial burdens associated with delays to the trial.
Meeting the technological needs of the trial
Clinical research organizations have the needed infrastructure and are equipped to meet the clinical and technological requirements of a clinical study, when a sponsor may otherwise not have been able to. This could relate to everything from SOPs, Clinical Trial Management System, subject enrolment tools, to data collection system, biostatistical and data management programs.
Time-saving
If a sponsor was required to create or obtain everything necessary to run a clinical trial, this would take years to commence. A clinical research organization already has all these necessary resources, meaning that a trial can get up and running significantly faster with a CRO for healthcare.
Navigating evolving and complex regulatory requirements
Clinical trial regulatory requirements are ever-changing, complicated to navigate, and often region-specific. A contract research organization can coordinate with regulatory personnel and ensure that necessary approval from the relevant regulatory bodies is obtained prior to the start of the trial. Throughout the trial, a CRO ensures all regulatory requirements are adhered to.
How to choose a Contract Research Organization
Depending on the requirements of a specific clinical trial, a sponsor may have a large number of seemingly suitable contract research organizations to choose from. When assessing which CRO is the best for your specific needs, consider the following factors:
● Is the CRO responsive, communicative, and collaborative? ● Does the CRO have relevant experience? ● Do they have an established quality system and QA processes? ● Is there a high turnover of clinical research associates (CRAs), or is staffing stable? ● What are the services the CRO offers?
These questions, along with others specific to the nature of your clinical trial, will help you find a CRO that gives you the peace of mind that your trial management is in safe hands.
CRO services with Gsap
Gsap is a full-service CRO with significant experience in the design and execution of clinical trials. Whether running an early-phase PK study, or an advanced-stage clinical trial, Gsap can provide the support you need to ensure success each step of the way.
A boutique CRO offering personalized support
Gsap is a boutique CRO, which means that you have more than just an organization to manage your trial – you have a partner you can work with every step of the way. Gsap delivers undivided attention to sponsors, both large and small.
Broad experience across multiple disciplines
Gsap’s CRO services span a diverse array of disciplines, including medical devices and digital health. Gsap also specializes in the rapidly growing field of medical cannabis, as well as cell and gene therapy, and the development of new pharmaceutical drugs and biologics.
End-to-end clinical trial support
Gsap is able to provide services that cover all the stages of a clinical trial. Before your trial commences, Gsap offers study design, planning, regulatory submissions, and site selection services. When a trial is wrapping up, Gsap delivers study reports, closes out study sites, and analyzes the associated trial data and writing interim and final reports.
Customized clinical trial services
By design, no two clinical trials are identical. Therefore, Gsap tailors its clinical trial services to each sponsor, to ensure the needs of your specific trial are met, based on your product’s characteristics and the geographical location(s) of your trial.
Gsap has helped numerous clients successfully manage the transition from pre-clinical development to clinical studies and can support your trial from start to finish. The Gsap holistic approach to CRO services helps to ensure the success of your own clinical trial.
Contact Gsap today to discuss your upcoming clinical trial.
This article was prepared by:
Matti Hoggeg, M.Sc.
Clinical Section Manager
For more information about our CRO services visit:
Learn what is A clinical trial protocol, why it’s important, what the protocol should include, and how to conduct a clinical trial with a CRO This article will address the following topics:
Clinical trials must strictly adhere to detailed protocols, which dictate every aspect of a trial. The clinical trial protocol documents the objectives, study design, methodology, statistical analyses, and general organization of a planned trial. It’s a critical document that helps to ensure that all data collected is robust, and also that the safety of trial participants is guaranteed.
What is a clinical trial protocol?
A clinical trial protocol is a written document that forms the backbone of the clinical trial. The protocol is finalized before any clinical trial activities commence, and must be observed and adhered to throughout the trial. A clinical trial protocol provides answers to many of the critical questions that come with a clinical trial, including:
● Why is the clinical trial being conducted?
● What are the questions that will be examined?
● How will the clinical questions be measured?
● Who can participate in the trial?
● What are the procedures that will be done during the trial?
The clinical trial provides details for physicians, study coordinators, and other staff regarding how to execute the trial. It also describes timelines for the trial, as well as ensuring data integrity and patient safety.
Before the trial commences, the protocol must be submitted for review by an ethics committee and be granted formal approval.
Why is a clinical trial protocol important?
A clinical trial simply can’t be completed without a clinical trial protocol. The protocol essentially acts as a set of quality control guidelines, put in place to protect both the participants in the trial and the integrity of data collected throughout the trial, and to ensure uniformity in the execution across all participating sites.
Specifically, a clinical trial protocol is important because:
● It ensures the safety and health of all participants in the clinical trial
● It details a strict and accurate study plan that all physicians, study investigators, coordinators, and trial staff must follow accordingly
● It ensures consistency in data collection and integrity, meaning that data from multiple different study sites can be compared or compiled
● Approval from ethics committees for the conduct of clinical trial cannot be granted without a robust clinical trial protocol
As you can see, the clinical trial protocol is crucial to the success of the trial itself.
What should a protocol for clinical trials include?
A clinical trial protocol needs to include all the information required to carry out the trial. More specifically, the protocol follows good clinical practice (GCP) guidelines or the closely related ISO 14155 guidelines for clinical trials of medical devices. GCP is an international ethical and scientific quality standard, which dictates how clinical trials should be conducted, and the roles of investigators, review boards, sponsors, monitors, and other stakeholders.
So, now that we know what a clinical trial protocol is, here is an overview of what needs to be included in a clinical trial protocol:
Purpose of the clinical trial
The clinical trial protocol must provide enough background information and rationale to outline the purpose of the trial, and justify why the trial is being conducted. The purpose of the trial will likely depend on the phase of the trial; earlier phase trials are usually to collect safety data, while later phase trials are to examine efficacy.
Trial outcomes and measures
The clinical trial protocol also needs to outline the measures that will define whether or not the trial is deemed successful. The protocol must detail measures that assess the safety and, if relevant, efficacy. Typically, a trial has one or two primary objectives and a few secondary or exploratory objectives.
Study participant criteria
Any given clinical trial has a strict set of guidelines relating to who can and cannot participate in the trial. These inclusion and exclusion criteria depend (among other things) on the disease being studied and the treatment being evaluated. For example, participants in a trial drug efficacy trial will likely need to have the condition or disease that the drug is being evaluated for. Exclusion criteria that could prevent a patient from participating in a trial may include age, medical history, or other medications that the patient is currently taking.
Study design and details
Other elements that need to be included in a protocol for a clinical trial include:
● The length of the trial and the number of participants needed
● The schedule relating to the frequency and duration of clinical visits for participants
● Suitable control measures, and whether or not some participants will be issued a placebo
To summarize, a clinical trial protocol must satisfy GCP guidelines, therefore ensuring both the integrity of the trial and the safety and well-being of trial participants.
Conducting a clinical trial with a CRO
As shown above, a clinical trial protocol needs to be extremely thorough and provide all necessary information to satisfy GCP guidelines and ethical considerations. If a clinical trial protocol is incomplete or insufficient, the trial will likely not receive ethics approval, and therefore cannot proceed. In addition, the trial objective must be carefully considered for the trial to meet the target and succeed.
Given that the clinical trial protocol is such a critical component of the trial itself, and essentially dictates how the trial will proceed, it is often necessary to enlist the services of a professional clinical research organization (CRO). A CRO works closely with the study sponsor to ensure that the clinical trial protocol contains all the necessary details for the trial to be approved.
CROs offer medical writers, clinical experts, and regulatory specialists that can assist in the clinical design and protocol development of your trial.
Clinical trials with Gsap
Gsap is a full-service CRO with years of experience in the design and execution of clinical trials. Gsap offers a team of professionals that can work with you to develop the clinical trial protocol, along with providing any other support your trial needs.
A boutique CRO providing personalized support
As a boutique CRO, Gsap ensures that you have more than an organization to develop your clinical trial protocol and manage your trial – you have a partner to assist you every step of the way.
Gsap has helped many clients create clinical trial protocols and manage the transition from pre-clinical development to clinical studies. The Gsap holistic approach to CRO services helps to ensure the success of your own clinical trial.
Contact Gsap today to discuss your upcoming clinical trial.
This article was prepared by:
Matti Hoggeg, M.Sc.
Clinical Section Manager
For more information about our CRO services visit:
In this article, we will discuss clinical trial monitoring in great detail, including what it is, what processes are involved, and why it is essential for the success of any clinical trial.
Clinical trial monitoring refers to the process of overseeing the progression of a clinical trial. Monitoring in clinical trials involves supervising consent documentation, protocol compliance and adherence, data collection and review, safety data collection and reporting, and much more.
The Importance of Clinical Trial Monitoring
The importance of clinical trial monitoring cannot be overstated. Rigorous monitoring is essential for several reasons, including: To ensure that human subjects are treated ethically and their well-being is protected
● To ensure that all data collection is consistent and accurate, particularly across multiple trial sites
● To ensure that all reported data is complete, accurate, and verifiable, with source documentation
● To ensure that the trial is carried out according to the outlined and approved study protocols and SOPs
Clinical trial monitoring is critical to ensure that accurate, reliable data is collected in an ethical manner throughout the trial process.
The Purpose of Clinical Trial Monitoring
The primary purpose of clinical trial monitoring is to scrutinize and verify the quality of the trial at every stage. Monitoring ensures that a trial is conducted according to the study protocol, with all necessary recording and reporting following the relevant standard operating procedures (SOPs), as well as regulatory requirements and Good Clinical Practices (GCPs).
The Three Types of Clinical Trial Monitoring
Clinical trial monitoring falls into three broad categories.
These include:
On-site
On-site clinical trial monitoring requires in-person assessment, carried out by clinical staff or sponsor personnel, at the trial site. On-site monitoring is the traditional form of clinical trial monitoring and was the most common form of clinical trial monitoring prior to the COVID-19 pandemic.
Remote
Remote monitoring in clinical trials has become more accepted in recent years. Unlike on-site monitoring, monitors do not visit trial sites during remote monitoring in clinical trials. Instead, data review and transfer are done using secure, specially-designed digital platforms.
Centralized
Centralized monitoring in clinical trials is the most appropriate option when there are multiple trial sites. Centralized monitoring arose due to the publication of guidelines relating to risk-based monitoring (RBM), and involves the collation of data from all trial sites to a central location for real-time evaluation.
The Services of Clinical Trial Monitoring
As mentioned, monitoring clinical trial processes involves a diverse number of services. These are some of the key elements of clinical trial monitoring:
Protocol compliance and protocol deviations
Strict adherence to study protocols and SOPs is essential in any clinical trial. The study protocol is written, reviewed, and approved prior to the commencement of the study, and any changes to the protocol, or deviations from the protocol, need to be appropriately documented throughout the trial.
Data collection and missing data
Another clinical trial monitoring service is the oversight of data collection. Clinical trial data must be accurate, complete, and verifiable from source documentation. It’s the role of a clinical trial monitor to ensure that this is the case. In addition, the collection of participant data needs to be performed according to the relevant data protection and privacy laws/guidelines.
ICF and Consent Process Review
Informed consent forms (ICFs) are a critical component of patient enrolment. Part of the process of clinical trial monitoring is to oversee patient enrolment and ensure that informed consent from each subject is appropriately obtained and documented.
Source data review (SDR) vs source data verification (SDV)
SDR and SDV are important elements of risk-based quality management. SDV refers to the process of confirming that reported analytical data accurately reflects the source data collected at the trial site, primarily on the case report form (CRF).
On the other hand, SDR refers to the review of source documents as they related to the clinical trial protocol. Compared to SDV, SDR involves a more strategic approach that focuses intently on the quality of data collection and compliance with regard to the study protocol.
IP/device compliance
An investigational product (IP) is a drug or biological product being used in a clinical trial, while an investigational medical device is typically a physical object (such as a pacemaker). Regardless of whether a trial is assessing a product or a device, compliance is integral to the trial’s success. A clinical trial monitor is responsible for ensuring compliance when it comes to how the investigational product or device is used in relation to the study protocol.
Safety data collection, review, and reporting
Safety data is one of the most important pieces of information gleaned from the study. Many trials are conducted solely to determine the safety of a potential new drug or device. During the study conduct safety data is collected and reviewed on an ongoing basis in order to ensure subject safety and safe flow of information.
Documentation review and collection
Clinical trial monitoring also involves the collection and review of the numerous documents associated with clinical trials. This process may include a review of CRFs, ICFs, and other source documentation such as hospital records and laboratory notes, and the collection of essential documents required to be part of the Trial Master File (TMF), which is the main repository of trial documentation. A critical component of document review is ensuring that all documentation is complete, legible, accurate, version controlled, and contemporaneous.
Equipment, ancillary supply, and logistics
All equipment being used in a clinical trial such as thermometers, centrifuges, etc. must be appropriately calibrated and validated, with associated documentation such as SOPs, logbooks, and training forms. Clinical trials also require a large number of ancillary supplies such as diagnostic and testing materials, and more. All equipment and materials used in or associated with clinical trials must be GCP grade, stored, and used appropriately. Coordinating this is a critical part of clinical trial monitoring.
Clinical Trial Monitoring with Gsap
Without adequate clinical trial monitoring, significant time and money may be wasted on a trial that does not meet the necessary quality standards for successful submission or review. An experienced and trusted contract research organization (CRO) can ensure that all elements of your trial run smoothly.
Gsap is a boutique CRO with vast experience across a wide range of clinical trial therapeutic areas and phases including cell therapy, gene therapy, cannabis, MD, and DH. Contact Gsap to discuss your upcoming clinical trial.
This article was prepared by:
Matti Hoggeg, M.Sc.
Clinical Section Manager
For more information about our CRO services visit:
