Medical review of clinical trial documents [e.g., Investigator’s Brochure, Protocol, Case Report Form (CRF), Informed Consent Form (ICF), Statistical Analyses Plan (SAP), Data Validation Plan (DVP), Edit Check Specifications (ECS), Safety Reports, SAE Narratives, Subject Narratives, Clinical Study Reports (CSR)]

Assistance for site selection and qualification

Development of study specific Medical Monitoring Plans

Training the project and site teams on the therapeutic area and medical aspects of protocol

Assistance to sites for selection of right subjects through pre-screening and eligibility assessments

Continued medical support to sites such as addressing protocol queries, dosing queries, medication queries, etc.

Review of study data:

• Efficacy data

• Safety data such as Adverse Events, Serious Adverse Events (SAEs), Physical Examination, Vital Parameters, Concomitant Medications, Laboratory Data, etc.

• Study drug dosing and compliance

• Protocol deviations with analysis of impact on study endpoints

• Medical Coding

• Subject Profiles

Data review and trend analysis of screen failure, premature discontinuations, AE/SAE and others

Real-time Identification of Risks with their mitigations

Generation of Periodic Medical and Safety Reports

Representation in Safety Review Meetings

Participation in Blinded Data Review Meetings

Review of Statistical Analysis Reports and Statistical Tables, Listings and Graphs