NexusCRO provides a range of integrated services that cover the planning, management, execution and analysis of Phase I – IV trials.

NexusCRO's fastest-growing therapeutic area and testament to our success in conducting oncology clinical trials.

NexusCRO's experience in cardiovascular trials is supported by a global team of cardiovascular experts.

NexusCRO will be able to advise sponsors exactly how many patients match their clinical trial criteria.

Regulatory Affairs

We at NexusCRO, also provide consultation to our clients on :

  • Methodology to approach the regulatory bodies.
  • Regulatory submissions / Product registration dossiers.
  • Time management (Faster Regulatory Approvals).

  • (Asiatic clinical)We support our client's product development programs by playing a pivotal role in obtaining regulatory approvals in the shortest possible time. We have a dedicated in-house regulatory team which assists in a broad range of Regulatory Consultations for most effective approvals and strategies. We cater from local to global submissions. Having a better understanding of the Indian regulatory scenario, we provide the best assistance to resolve any queries raised by the "Drug Controller General of India" (DCGI) and follow-up submissions for faster approvals.

    What we do for you:

    • An initial assessment of your data to maximize the possibility of rapid clinical trial approval
    • Preparation of Regulatory Dossier.
    • Regulatory strategy planning for faster approval.
    • Filing of submissions, tracking submissions & query resolution.
    • Post - approval regulatory submissions (amendments).
    • Submission of final study reports.
    • Preparation and submission of Product Registration applications, to import, manufacture and market in India.
    • Complete Import & Export License Management for clinical supplies and biological product and samples.
    • Collecting, reviewing and updating all national legislation related to clinical trials to ensure full compliance with all applicable.

    • IRB/IEC Submissions:

      • NexusCRO is familiar with Ethics Committee requirements. Its reputation for an active follow-up of protocol submissions ensures fast turn-around time.
      • Familiarity with local requirements and practices is important in avoiding unnecessary delays when embarking on studies. With extensive experience in obtaining IRB/IEC approvals, NexusCRO professionals bring these assets to your clinical development programmes.