In an increasingly competitive marketplace and ever changing regulatory scenarios, our expertise can make tangible difference in your clinical development program. With our extensive experience across a wide range of therapeutic areas and multiple development phases, we carry following exclusive expertise in the area of clinical development.
Biosimilar and Biologics: Biosimilar and Biologics are different from small molecules and require much micro level planning at all levels. We have to consider many small issues like cold chain breaks, window period break up of dosing schedule, drugs administration and storage at home in case if trial involved drug administration daily. Our expertise in this area gives us strength to plan, predict and manage many operational issues at the beginning. This will help us not only to reduce the cost but also manage operational efficiency.
Patient Recruitment and Retention: Patient enrolment is the most time consuming aspect in any clinical trial. Most of the time, delay in patient recruitment is one of the leading cause of missing overall program deadlines. We have expertise in population research to assess country specific recruitment timelines and to evaluate further whether given country is suitable for program or how effective would be the enrolment. Suggestion of scientific and operational modification in the protocol to enhance recruitment, reduce drop out and screen failures to optimise the overall patient recruitment are part of our expertise characteristics.
Bioequivalence Study with Clinical Endpoints: Our strategic approach for successful completion and regulatory acceptance of Bioequivalence Clinical Endpoints Study is coming from our experience. We have expertise to understand regulatory challenges, regulatory filing requirements, optimal sample size calculation to prove clinical equivalency, retention of IP and blinding. Our medical writing expert knows how to design study assessment questionnaires and how to train investigators on rating of these assessments. We make the better proposition by integrating above expert knowledge for planning and execution of Bioequivalence Clinical Endpoints Study.
Risk Based Monitoring: we have capability to provide you alternative monitoring method that can improve the quality and efficiency of clinical trial monitoring at investigative site. We can approach risk-based monitoring model mainly focused on most critical data elements necessary to achieve study objectives. In Risk-Based Monitoring, we monitor data quality through routine review of submitted data and follow-up for critical element and conduct statistical analyses to identify early trends .Our risk-based Monitoring plan would include proportionate combination of remote as well as on site monitoring.