Feasibility & Protocol Development in Clinical Research.

Worldwide Clinical Trials is recognized for customized feasibility and protocol development evaluations in clinical research. Providing accurate, comprehensive, and thorough recommendations, our global team utilizes data and collaboration to develop customized strategies. Our approach is highly flexible, allowing us to continually adapt our strategy to align with the ever-changing regulatory landscape.

Feasibility

With feasibility experts all over the world, our global reach, combined with our medical and scientific expertise, ensures we provide the best possible solutions to your program. Feasibility data is analyzed, summarized, and graphically presented to convey supporting data and facts that assist with the optimal development of your clinical research program.

This customized data includes:

• Protocol feasibility: To identify potential problems impacting study execution and assess ideal protocol design for a study’s purpose
• Strategic feasibility: To leverage information from relevant data sources to determine the optimal country-site patient distribution and enrollment timelines for the study
• Country feasibility: To select the best locations to conduct the study
• Guidance: To ensure timely study implementation and proper execution with solutions to roadblocks to patient randomization and retention

The feasibility team is here to partner with you and serve as a contact point to communicate with all of Worldwide’s skilled teams. We ensure sponsors get on the right path for their program and stay on that path throughout the duration of their trial. We do so by adopting an analytical approach, quantifying what we can while layering in qualitative experiences to collectively determine the best path forward.

Our feasibility team is truly collaborative in nature, partnering with Operations and Regulatory while working with various teams across Worldwide, including Site Activation, Global Site Alliances, CTLs, Sales, TSLs, Scientific, and Medical.

Questions We Ask:

• Is the protocol written well?
• Is the protocol realistic and ethical to perform?
• Do the endpoints answer a scientific question of value?
• How many sites and enrollment months are needed to enroll the needed number of patients?
• What are the optimal countries to involve?
• How many sites and patients can be expected per country?

Protocol Development

Methodological rigor integrated with operational insight is at the heart of protocol development at Worldwide Clinical Trials. We apply it from first-in-man trials to post-approval investigations to highlight the clinical attributes of a new product before commercialization.

Our protocols are always developed collaboratively, with each undergoing full verification through the operational components of the organization. We only recommend a protocol or proposed program with complete knowledge of the logistical and financial implications, as well as the clinical and regulatory implications.