Learn what are Clinical trial services and why they are important, and explore the different types of clinical trial services
This article will address the following issues:
1. Clinical Trial Services
2. Common Types of Clinical Trial Services
3. Clinical Trial Services with Gsap
Clinical Trial Service
Clinical trials require extensive experience, planning, and execution. With major investments, both in terms of finances and time, it’s crucial to ensure that every step is executed according to plan, from initial protocol development to data analysis. With Gsap, you can be sure that your trial will be carried out to the highest standard, and in compliance with all relevant regulatory requirements.
What are Clinical Trial Services?
Clinical trial services is a broad term that can pertain to any number of outsources services provided during the clinical trial process. Clinical trial services can include everything from the initial protocol development and study planning, to trial execution and data management, and the final data analysis and reporting.
The highly regulated nature of clinical trials, and the necessity to justify every decision made throughout the process, means that outsourcing clinical trial services can bring major benefits. A CRO (clinical research organization) can manage every aspect of the trial process and has the necessary network of suitable sites, professionals, and infrastructure.
(clinical research organization)
The Importance of Clinical Trials
Clinical trials are essential for the advancement of safe, effective treatments across all fields of medicine. Whenever a new treatment is developed, such as a drug, vaccine, or medical device, clinical trials must be performed to first assess safety, then efficacy. Drug dosing, contraindications, and additional crucial data can also be gleaned from clinical trials.
While in vitro and animal studies can play crucial roles in early-stage medical research, such as the identification of potential new therapeutic drug compounds, there is simply no substitution for clinical trials. Trials in human subjects, under strictly regulated and controlled conditions, are essential in the evaluation of a new drug, treatment, or medical device.
The Value of End-to-End Clinical Trial Services
End-to-end clinical trial services, or full-service clinical trial management, involves utilizing the expertise of a CRO for the entire clinical trial process. This brings invaluable consistency to your clinical trial, saves significant time in document preparation, and ensures you can work with a trusted partner who understands your goals and priorities.
Common Types of Clinical Trial Services
There are many elements of a clinical trial, all of which must come together to produce the final product. The main types of clinical trial services include:
Clinical trial design and planning
Trial design and planning is arguably the most important element of a successful clinical trial. By enlisting a CRO to assist with establishing the framework for your trial, you bring invaluable expertise from professionals who understand the objectives of your trial and can ensure your study timelines are adhered to.
In the planning and design phase alone, you can save significant time by utilizing a CRO to provide clinical trial services. A CRO can use its extensive network to coordinate everything from study timelines to site selection, ensuring your trial is set up for success from the very beginning.
Clinical trial regulatory services
The regulatory element is a key component of clinical trial services. Thorough documentation, before, during, and after the trial, is essential. Clinical trial regulatory services typically include the preparation of study protocols, which dictate every step of the clinical trial process and include the objectives.
Other necessary documentation that is usually covered in clinical trial regulatory services includes the investigator’s brochure (IB), and informed consent forms (ICFs), which provide a thorough analysis of the potential risks and benefits of clinical trial participation.
A CRO can aid in the management of multiple regulatory submissions, as well as preparing all documentation for ethics committees and other regulatory bodies, such as government agencies (MOH, FDA, etc). Outsourcing such regulatory tasks to CRO specialists results in faster trial start-up and follow-through times, which in turn can lead to significant financial savings.
Medical writings
Clinical trial study reports and associated documentation is a major component of the clinical trial process. Furthermore, there are highly specific guidelines relating to how all documentation must be written and submitted. A CRO that offers specialized medical writing services can save you significant time, and also reduces the risk of delays resulting from missing or incorrect documentation.
Clinical trial management
Overseeing a clinical trial, both in terms of the day-to-day processes and adherence to all protocols and SOPs, and the broader study progression relative to the required timelines is a monumental task. Trial management is a key clinical trial service provided by CROs, and involves everything from site selection to qualification of the study team. Budget oversight is also a critical component of clinical trial management.
Clinical trial data management
Data management for a clinical trial begins long before the trial itself. Planning what data will be collected, at which time points, and how it will be collected, stored, and interpreted, is an essential part of the clinical operation. Data management is a key clinical trial service offered by CROs, and gives you the peace of mind that all trial data is collected in line with both the clinical protocol and relevant regulatory guidelines.
Clinical trial monitoring
Clinical trial monitoring involves rigorous oversight of the study, including documentation, data collection, addressing protocol deviations, oversight of the study team, on site and remote visits, staff training, and more. Enlisting a CRO for clinical trial monitoring services helps to alleviate logistical challenges, keep trial timelines on track, and helps to ensure a smooth path to data cleaning.
Quality assurance (QA)
Another critical element of a clinical trial is quality assurance (QA). QA is responsible for the thorough, unbiased examination of all trial-related documentation. This includes the analysis of SOPs, plans, and protocols prior to the commencement of the trial, as well as all batch records and data collected during the trial.
A rigorous and experienced QA team is essential to ensure that the data collected in a clinical trial, and the manner in which it is collected, meet the necessarily stringent regulatory guidelines.
Clinical Trial Services with Gsap
Gsap is a boutique CRO that offers a wide range of clinical trial services, delivered to the highest standard. With hundreds of satisfied clients ranging from small-scale startups to large international companies, Gsap specializes in trial management across different disciplines, including MD, DH, medical cannabis research, as well as cell and gene therapy.
For end-to-end clinical trial services that can help ensure the success of your trial, contact Gsap.
This article was prepared by:
Matti Hoggeg, M.Sc.
Clinical Section Manager
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