Month: November 2022

Just like any project, a clinical trial requires stringent management and control of everything from budgets to timelines and collaborators. Clinical trial project management involves thorough oversight of the clinical study, beginning before the planning phase commences, and continuing through the data analysis and submission period.

This article will address:

1. What is Clinical Trial Project Management?
2. The Importance of Project Management for a Clinical Trial
3. What are the Roles of a Clinical Trial Project Manager?
4. Clinical Research Project Management with Gsap

What is Clinical Trial Project Management?

Simply put, clinical trial project management describes the steps and processes that an organization puts in place to ensure that a trial is carried out at the highest standard. Clinical trial project management is typically carried out by a clinical research organization (CRO). 

A big component of clinical research project management is ensuring the overall quality of a study; that the resulting data is reliable and robust, and that risk management and patient safety are prioritized throughout the trial. Another aspect of clinical research project management is the time management of the study, ensuring that the trial is completed according to the relevant timelines and deadlines. 

The Importance of Project Management for a Clinical Trial

Without proper project management, the quality of the data generated from a clinical trial and the progression of the trial itself may not be up to the necessary standard to reach regulatory approval. With so many critical components, like managing partnerships with third-party vendors and suppliers, adhering to timelines, training all necessary staff, controlling all relevant documents, and much more, clinical trial management is essential to the completion of a successful and high-quality clinical trial. 

What are the Roles of a Clinical Trial Project Manager?

A clinical trial project manager is a multi-faceted role with many different responsibilities. Some of the primary roles of a trial manager include:

Overall overview and responsibility of study conduct

While various individuals are responsible for specific aspects of a trial, like clinical data collection, quality assurance, site activation, and so on, the clinical trial project manager plays a broader role in the oversight of each of these elements. A crucial component of clinical trial management is coordinating with all specialists and individuals involved in the study to ensure a successful clinical trial. 

Study planning and set up

A clinical trial begins long before the first patient sample is collected. Significant study planning and coordination must first be carried out, and extensive document preparation (including study protocols, SOPs, ICFs, and more) is undertaken prior to the commencement of the trial. Study planning plays a large role in clinical trial project management, and it is critical to work with a clinical trial manager who is able to understand the needs and objectives of the trial, in order to ensure timely progression and compliance of the study. Comprehensive planning for the study start will pay off during the study conduct and save time and budget. 

Vendors selection

In a majority of cases, a clinical trial can not be executed by a single study team. Third-party vendors are often included in clinical trials to offer expertise regarding specific technologies or specialized clinical procedures associated with patient sample collection. Typically, there are multiple qualified vendors to choose from. Selecting and vetting the most appropriate vendor(s) is another role that falls under clinical research project management. 

Milestones follow up

During the planning phase of a clinical trial, milestones should be established to outline various steps and stages throughout the trial. Milestones may include protocol finalization, regulatory and ethics submission deadlines, study site activation, first subject in/out, last subject in/out, completion of data review and statistical analysis, and site closeouts. The clinical trial project manager is responsible for following up on each milestone as the trial progresses, to ensure that all deadlines are met and the study progresses according to the initial study plan.

Communication and escalation

Effective communication is an essential skill that is required by all clinical trial project managers. Communication with stakeholders, within study teams, between sites, with third-party vendors, qualified personnel, and also to regulators and auditors is critical to the progression and success of the clinical trial. The project manager must also understand when to escalate any issues to the appropriate personnel. The clinical project manager is responsible for internal and external communication as well as action items follow-up, milestones etc. The Communication processes enable the Sponsor and stakeholder to be on the same page and progress the project vectors to the needed direction at each time point. 

Collaboration with all parties and vendors

As well as initially selecting vendors, the project manager must maintain a collaborative relationship with vendors throughout the study. Successful clinical project management involves close communication and cooperation with all vendors and third-party players. When it comes time to submit final regulatory documentation, the project manager must coordinate with all stakeholders and vendors to ensure the appropriate materials and documents are obtained and submitted.

Timeline and budget oversight

Clinical trials are inherently expensive, and poor project management can lead to study delays, which further increase the costs associated with the trial. Clinical research project management is primarily focused on adhering to timelines and budgets, with the overarching goal being to ensure that the trial is completed according to schedule, and within the outlined budgets. 

Study team management, interphases, guidance, and training

Coordinating, guiding, and managing the study team (including clinical research associates, statisticians, QA personnel, medical advisors, and site staff) is another key role of the project manager. Ensuring that appropriate personnel is fully trained according to study protocols and SOPs (and that training is comprehensively documented) is essential in clinical project management. 

Project Management Plans 

The project manager is responsible to ensure that each component of the study has a plan in place which is comprehensive, study-specific, current throughout the study, and updated as needed in order to cover all study aspects. The plans include a Clinical management plan (CMP)  that outlines the scope and study-specific procedures, a Quality plan that ensures QC and QA procedures will be performed throughout the trial, a Data management plan (DMP) which outlines the plan for the collection and management of clinical data throughout the duration of the trial and more as needed. 

Risk management

Assessing and managing risks is a significant element of clinical trial management. Risks might include IRB approval delays, issues with patient recruitment, unexpected staff turnover, unplanned protocol changes, etc. The role of the clinical project manager is to assess the probability of a given risk occurring, the impact that it would potentially have on the trial, and, of course, how to mitigate each outlined risk. 

Clinical Research Project Management with Gsap

Gsap is a boutique CRO with vast experience managing a diverse range of clinical trials, including in the pharma, Medical Device, Digital Health, Diagnostics, cannabis, and gene/cell therapy fields. Gsap’s vastly experienced team can manage your project in close collaboration and partnership with all relevant parties and vendors, with respect to timelines, milestones, training materials, sites support, in-house monitoring, open action follow-up, eTMF, CMP, and internal SOPs. This approach ensures a high level of project management and quality of study conduct, leading to the success of your trial. To learn more about Gsap’s clinical trial project management services, contact Gsap here. 

This article was prepared by:

Matti Hoggeg, M.Sc.

Clinical Section Manager

For more information about our CRO services visit:

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

For more information about our CRO services visit: