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Clinical Trials

Clinical Trials

Bringing a medical device to market requires clinical evidence that is scientifically sound and regulator-approved. We design and manage end-to-end clinical trials that ensure safety, compliance, and faster approvals. From protocol development to post-market follow-up, our services help you meet global standards (CDSCO, FDA, CE) while keeping studies efficient and cost-effective.

Protocol Development

  • Scientifically Sound Design: Draft protocols aligned with global standards (CDSCO, ISO 14155, ICH-GCP).
  • Reliable Foundations: Ensure methodology, endpoints, and safety are clear for successful trial execution.

Biostatistics Analysis

  • Robust Trial Planning: Calculate sample sizes and design statistical analysis plans.
  • Strong Evidence: Provide post-trial statistical evaluations that strengthen regulatory submissions.

Site Identification

  • Right Locations: Select trial sites based on expertise, investigator credentials, and infrastructure.
  • Fast Enrollment: Use established hospital and diagnostic center networks for efficient patient recruitment.

Institutional Ethics Committee (IEC) Approval

  • Complete IEC Support: Prepare and manage protocol packages, consent documents, and submissions.
  • Accelerated Timelines: Address IEC queries effectively to speed up trial initiation.

CTRI Registration

  • Regulatory Transparency:  Manage Clinical Trials Registry–India submissions and compliance.
  • Efficient Approvals: Handle documentation, submission, and follow-up to secure clearances quickly.

CRA & Investigator Training

  • GCP Compliance: Provide training for Clinical Research Associates and Investigators.
  • Better Outcomes: Ensure site personnel are aligned with regulatory expectations and safety standards.
  • Ongoing Compliance Support: Continuous advisory to keep businesses aligned with evolving regulations.

Subject Enrollment

  • Targeted Strategies: Design recruitment plans that identify and enroll eligible participants.
  • Retention Focused: Manage consent and retention processes to reduce dropout rates.

Data Collection

  • High-Quality Capture: Implement paper-based or eCRF systems for accurate data.
  • Regulatory Ready: Ensure source data verification and real-time monitoring for compliance.

Data Analysis

  • End-to-End Analysis: Perform statistical evaluations aligned with the approved analysis plan.
  • Defensible Outcomes: Deliver scientifically sound results ready for regulatory review.
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