Biomedical research study

Pepgra is your reliable CRO. Our experts in scientific, clinical, regulatory, and statistical study will design your clinical protocols and execute trials.

Clinical study design and protocols that balance the interests of multiple stakeholders

To estimate the magnitude of treatment effect or difference in the treatment effect, there is a need for a good trial design approach that allows the treatment effect to be sorted out from person-to-person with variation in the responses. With a better-informed protocol, clinical trials can answer the objectives of the study while reducing the bias in estimating treatment effects thereby reducing the overall time, costs and also increase value to stakeholders.

At Pepgra, we are sensitive to the need of balancing scientific, regulatory and logistical concerns to design and plan a successful clinical investigation. Our team has experience in developing study design for both new drugs and medical device despite the risk stratification (or class) of the device. Our experts develop study design based on strong scientific evidence, and our study design experts regularly advise on the necessity, implications, and practicality of clinical study design factors.

Clinical Study Design Solutions

• Clinical hypothesis consultation
• Endpoint selection and confirmation
• Statistical sample size calculation
• Adaptive Design Clinical Trial (after initiation without undermining its validity and integrity)
• Protocol writing and Protocol review
• Randomization
• Interim analysis
• Resource planning
• Cost estimation
• Case report form (CRF) design
• Literature review
• Regulatory counsel
• Sample size calculations and power analysis based on the published data or pre-existing study results
• Literature search and summary
• Randomization scheduling
• Statistical and analysis planning for clinical trial protocols
• Clinical trial Protocol writing and review
• Preparation of draft IDE submission, including protocol summary
• Participation in pre-IDE interactions with FDA
• Submission of IDE to FDA

The breadth and depth of their combined expertise bring efficiency to the process—helping you realize the full potential of your study design protocol.