Who We are


Health Care at Soft nerve is core focus area ,offering comprehensive services in Clinical Trial and Data Management With our subject Matter Experts team with ICH-GCP certification. Soft Nerve - Clinical Research ensure the feasibility analysis are done in advance before trial was started .

  • Vision - To be the most admired Site Management Organisation from India.
  • Mission - Soft Nerve Health Care is committed to provide ICH-GCP compliant services to ensure patient safety, quality data and meet international standards in clinical research.
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THERAPEUTIC AREAS


If you have the right talent & you are passionate towards solving real user problem with a single-minded focus. This is the right place for you to exhibit your Talent .

Core Expertise's


  • Site Management Support (S.M.O)Support
    • Review of site facility, resources, source documentation practices, EC’s SOP etc. and  up-scaling (as and where  required) to meet the ICH-GCP and applicable regulatory requirements (Schedule-Y).
    •   Identification and development of potential Principal Investigator(s) (PIs)
    • Assistance in the execution of Undertaking by the Investigator (Appendix-VII of Schedule-Y), Form FDA 1572,   Financial Disclosure, Clinical Trial Agreement, etc..
    • Communication with study Sponsor/C.R.O.
    • Translation and validation of ICF in required vernacular language(s).
    •  Preparation and submission of EC dossier and follow-up on queries (if any)
    • Development of site specific SOPs.
    •  Meeting the project timelines for patient enrolment and data management matrices
    •  Meeting the highest quality matrices for protocol compliance, patient follow-up, safety reporting, IP accountability, CRF completion (paper/e-CRF), and compliance with ICH-GCP and applicable regulatory guidelines
    •   Facilitate the monitoring visits by keeping all the essential documents up to date thereby reducing the monitoring time by 50%.
    • Turnaround time of 24 hrs. for any urgent queries from study Sponsor(s)/CRO(s)
    • Periodic reporting to EC (SAEs, safety alerts, protocol deviations, trial progress, etc.) as stipulated in the approval letter.
    • Keeping investigator sites ‘audit ready’ at any time-point.
  • Site Coordinator Support
    • Appointment of trained site coordinator for smooth execution of the trial in compliance with protocol schedule of events and applicable regulatory guidelines.
  • New Clinical trials coming soon.