Clinical Development

The Clinical Development team comprises of experienced clinical research professionals and MD pharmacologists with extensive experience in a wide array of therapeutic areas. We offer broad study experience and knowledge of study requirements, risk management and best practice implementation. Together with our dedicated clinical and medical teams, we offer effective study design and management services. Our professionals collaborate to meet all regulatory, safety, and scientific requirements.

Services

Conceptualization of Study Design

The Clinical Development team applies its expertise to develop effective and scientific study designs and protocols for clinical trials in consultation with therapeutic area experts ensuring scientific rigor and compliance with applicable regulatory guidelines. The feasibility assessment team conducts live feasibilities with the key opinion leaders on the study protocol before finalization.

Medical Writing

The medical writing team provides documents through an intensive internal review and quality assurance process. The team collaborates with biostatisticians and project team members to produce concise and comprehensive clinical trial documents like protocols and clinical study reports.

We also generate clinical study reports for regulatory submissions from the data analyzed in-house or from the external analysis.

Medical Monitoring

The team in consultation with the Sponsors develops medical monitoring plan and ensures that the trials are conducted in accordance with the study specific protocol and medical monitoring plan. Medical monitors are always available to provide answers to queries related to patient eligibility, protocol deviations and waivers.

Safety Reporting

Clinical Development professionals provide highly credible input for the design of safety management strategies and plans, to support regulatory acceptance of documents. The team has expertise to handle all the safety reporting requirements.