Overview

As the locomotive in Clinical Trials, our Clinical Operations department surely is the engine driving HeaDS Research forward. We take a lot of pride in our people and our international clinical operations team comprises of highly motivated individuals whom we continuously strive to develop professionally.

Being in very close collaboration with the Regulatory, Biometrics & Medical teams, our department engages in-house technology to streamline all operations, enhance data quality, ensure ‘inspection readiness’ and enable efficient oversight of vendors and sites for Interventional (Phase I-III) and Non-Interventional Studies. We will back any clinical decision making with hard data leading to a reliable and efficient clinical study outcome.

Services

Services

Clinical Monitoring

  • Feasibility analysis & Selection visits
  • Site Initiation, monitoring and close-out visits
  • Remote monitoring
  • Site management and issue handling
  • Maintenance of Study Files
  • Site payments

Project Management

  • Design & implementation of Project Plan
  • Monitoring of progress and performance against the project plan & milestones.
  • Risk Assessment & mitigation plans
  • Subject Recruitment and retention management
  • Generation of study material and plans
  • Organization of Investigator’s & Monitor meeting
  • Budget overview
  • Management of study specific Laboratory services;
  • Continuous Oversight of Study Compliance Metrics & Key Quality Indicators
  • Management of Drug Supply: Drug Forecasting, ordering, overview and destruction
  • Third party vendor management and oversight
  • Vendor Payments
  • Quality Check of Trial Master File

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