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Clinical Trial Protocol Execution within a Clinical Research Organization (CRO)

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Within a Clinical Research Organization (CRO) such as BioPharma Services, the successful execution of the clinical aspect of a study is a multidimensional and multi-faceted operation. The process often, if not always, involves multiple teams that must function as a syncytium in order for a study to be run smoothly. The clinical research coordinator, (CRC) is central to the success of this operation and the clinical research trial protocol execution.

Much like the Sinoatrial node serves to dictate the pace at which the heart beats, the CRC ensures that a study runs along with the pre-determined timelines and works to keep every integral part of the trial in the loop. The BioPharma team of clinical research coordinators includes an array of seasoned and experienced professionals who ensure smooth running of the clinical research trials in conjunction with the Principal investigators. The following will take an in depth look into the processes involved in clinical trial protocol execution. 

Clinical Trial Protocol Development and review

BioPharma Services has a highly qualified team of expert scientists who primarily develop clinical trial protocols in conjunction with sponsor-specific requirements. This process is all dependent on the investigational product and pre-determined study design. The clinical research coordinators are usually part of this process, as they have the hands-on knowledge on the day-to-day clinic activities that are involved in the running of the research trial.

In addition, all clinical trial protocol designs affect the actual conducting of the study. At BioPharma Services, the clinical trial protocol execution is designed to achieve the study purpose as well as ensure the feasibility for all clinic operations. 

Clinical Trial Protocol Foresight

One of the most important responsibilities of a clinical research coordinator is the ability to critically predict and foresee a study execution process, and this aids in avoiding exigencies as much as possible. Clinical trial protocol execution in an organized fashion as often done at BioPharma Services ensures that the clinical studies are conducted with as few as possible unplanned protocol deviations, thus translating into the eventual clinical study report which meets our client expectations. 

BioPharma Services have a team of clinical research coordinators who, based on their vast experience in different types of studies, can review a protocol and predict possible difficulties. They have the knowledge to hastily put into place the steps necessary to mitigate any difficulties and ensure that the study runs problem free. Our CRC’s are trained to examine the various processes involved and required to ensure the eventual success of the study. The delivery of a final clinical trial protocol must be satisfactory from both a regulatory perspective and quality point of view.

Preparation and Logistics Planning for Clinical Trial Protocols

Once the clinical trial protocol design is concluded and approved by the necessary regulatory authorities, the clinical research coordinator then begins to plan out the fine details of how the clinical trial will run. Every aspect of clinical trial protocol execution is taken into consideration at this stage. Any vendors and materials that are needed in the operations of the study, and which are required, must be set-up prior to the screening process to take place and this process varies from study to study as we run various types of clinical trials including simple and complex Phase 1 Clinical Trials, Human Abuse Potential studies, and other special; studies like Bioequivalence and Bioavailability studies. 

Managing Volunteer Expectations 

The clinical research coordinators are the point of contact for communication with volunteers and providing clarifications or updates as needed. BioPharma Services award-winning staff of clinical research coordinators are highly trained on clinical trial protocol execution, and possess the necessary know-how to appropriately engage subjects on whatever questions they might have. 

At BioPharma Services, it is generally understood that the volunteers are a vital aspect of any clinical trial and so care is taken that all activities are performed in accordance with the guidelines of Good Clinical Practice (GCP) to ensure that the rights and autonomy of the subjects are in no way trampled upon, all subjects are treated justly and with the utmost respect. 

Our high standards here at BioPharma Services ensure the safety of subjects is always a top priority and which is why, despite the severity of COVID-19 at its peak, we were able to successfully conduct human clinical trials without any outbreaks. The measures put in place that have ensured the safety of our volunteers is only one of the many testaments we have when conducting clinical trials.

Clinical Trial Protocol Timelines

As a clinical research coordinator, one of the most important factors to be considered is the timeline for the study, which is usually predetermined during the early stages of the study designs and clinical trial protocol development. The CRC ensures that all study related activities, source document review, queries resolution, tables preparation, and other required processes are completed efficiently. Lag at any stage would lead to a cascade of events that could result in the eventual delay in the study results and the final clinical study report. The BioPharma Services team includes clinical research coordinators who work tirelessly to assure product delivery that is on time.

The process of study coordination involves working with all departments including but is not limited to, the scientific medical writing team, Clinical research technicians, medical assistants, Nurses, quality control, quality assurance and project management to name a few. Being organized as a clinical research coordinator is a fundamental ability, while also coordinating with all the necessary departments. All these steps are needed to ensure the study runs smoothly and as required per the clinical trial protocol. 

The CRC and the Principal Investigator

To ensure smooth running of a clinical trial, the Clinical research coordinator and the principal investigator must be in constant and consistent communication. The principal investigators at BioPharma Services, Dr. Isabella Szeto for example, are very hands-on in their approach and try to be involved in every aspect of the trial. While this may not be possible each and every time due to other commitments, this why there is the necessity for a clinical research coordinator. 

The day-to-day running of the clinical trial is coordinated by the CRC under the instructions of the principal investigator and the overall guidance of the clinical trial protocol. The CRC constantly engages with the study volunteers and relays the feedback to the principal investigator on a pre-established basis.

The role of a clinical research coordinator during clinical trial protocol execution is therefore a very vital one. BioPharma Services is a leader in  Clinical Research Conduct and a fierce competitor within the global CRO industry. The BioPharma Services team has some of the most skilled hands available to ensure successful and seamless delivery of high quality human clinical trials. This is one of the many factors that has consistently kept BioPharma Services as an award-winning CRO, competing on a global scale.

Written by Oluwatobi Akangbe, Clinical Research Coordinator.

Find out why BioPharma might be the right partner for you! Learn more about BioPharma Services and the wide array of services we provide.

BioPharma Services, Inc., a Think Research Corporation and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with access to healthy volunteers and special populations.

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