Clinical Trial Project Management

Clinical Project Management

Clinical Trials

Clinical Trial Project ManagementOur clinical project management team has decades of  experience managing trials ranging from first-in-human proof of concept to multinational, multicenter, controlled pivotal trials. We emphasize efficiency in conducting clinical trials, while maintaining exemplary quality and compliance. Study documents and procedures are carefully designed to ensure a quality trial that produces the information needed to advance the development of your product or treatment. We focus on working with you to build the primary and ancillary goals for each clinical trial, and on building excellent relationships with the clinical trial sites to inspire the collection of timely and accurate data that are vital to the success of your trial.

Clinical Site Assessment

Enthusiastic, adequately staffed and expert clinical trial sites are essential to timely enrollment of patients and collection of reliable clinical trial data. Our experience with a multitude of trial sites around the world has taught us how to evaluate potential sites, and the right questions to ask to determine the best fit for each clinical trial. We also strive to see that candidate sites learn enough about the requirements of the clinical trial to determine whether it is a good fit for them as well. Smart site selection contributes greatly to completing a clinical trial on time and on budget.

Document Preparation for IRB/Ethics Committee Review

Institutional Review Boards (IRB)/Ethics Committees (EC) are convened to protect the health, safety, and welfare of human subjects. Research involving human subjects may only be carried out if an IRB/EC approves the research plan. A central IRB/EC can provide economies in clinical trial oversight. We can help you determine if a central IRB/EC is appropriate for your clinical trial; if it is, we can prepare and submit the necessary paperwork. If a clinical trial site needs to submit to its own individual IRB/EC, we can help to support the site staff in preparing their application to make a timely submission. Our experience with hundreds of IRB/EC submissions gives us the insight to create documents that will meet the IRB/EC’s requirements, thus maximizing the chances of a timely approval.

Clinical Site Initiation and Training

Clinical trial site staff (e.g., investigators and research coordinators) must be trained in the use of the investigational product, the patient informed consent process, proper collection of clinical trial data, and reporting requirements. Without effective site training, clinical trial data may be missed, collected improperly, or reported incorrectly. Proper use of the investigational product is imperative to minimize patient safety risks and to optimize the likelihood of study success. Training also helps sites conduct the clinical trial in accordance with applicable regulations and ethical guidelines. We focus on comprehensive site training with continuous performance monitoring to ensure clinical trial sites are providing the highest quality data. Intermittent retraining is performed as needed to ensure site performance throughout the duration of the clinical trial.

Clinical Trial Closeout

Each clinical trial site must keep copies of the proper documentation and submit a notice of clinical trial closure to its IRB/EC, usually including a final report generated by the clinical trial sponsor that summarizes the clinical trial results. We ensure sites have the necessary documentation and the staff are aware of their post-trial responsibilities. In cooperation with the sponsor, we create the final clinical trial report and help  sites meet every requirement to close out the clinical trial to the IRB’s/EC’s satisfaction.