Clinical Operations

Data Management


Medical Services


Central Laboratory

Quality Assurance


The Medical Monitoring Team at DiagnoSearch comprises of medical professionals who bring with them vast clinical research experience spanning across various therapeutic backgrounds. The Team provides a close supervision of medical aspects of a clinical trial and provides the following services customized to client requirements:

  • 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