NephroPlus Clinical Research: Enhancing Research and Ethics

Mission

To enhance and collaborate with Renal therapeutic partners across the globe and deliver ethical and on-biased clinical trial outcome.

Our Strength

  • 208 Centers across India across 120 Cities.
  • Centralized research staff and ground level staff.
  • Data for more than 16000 active Guests on Dialysis with wide range of Subtherapeutic areas.

 

Site Management Services

NephroPlus provides clinical research services for Academic, Pharmaceutical and Bio-technology products development from Phase – I to Phase- IV.

‘As per the GCP, clinical trials must be scientifically conducted using appropriate methods and ethical considerations, understanding regulatory requirements, carrying research expertise and project management at the same time’.

In order to fulfil these requirements, NephroPlus Clinical Research (CR) team functions separately along with the internal and external stakeholders.

NephroPlus has the complete infrastructure suitable for conducting trials with the Start-up, Conduct, Close out – Archival teams.

Scope of Services

I. Start-up Team

Our project management and start up coordinators support to the sponsor or CRO in:

  1. Feasibility
  2. Identify and support sub-therapeutic areas
  3. CTA (clinical trial agreements)
  4. Regulatory submissions

II. Conduct

Our project management and conduct team coordinators provide support in:

  1. Patient screening
  2. Recruitment plan
  3. Investigator training
  4. Study conduct as per the GCP and regulatory requirements
  5. Ethics committee submission and ongoing review and approvals
  6. Quality assurance

Our full time clinical research staff ensures planning and execution of clinical trials within the stipulated timelines.

III. Close out -– Archival

Our project managers and closeout coordinators along with archival specialist ensure:

  1. Systematic close out
  2. Planning according to the sponsor-CRO-regulatory requirements
  3. Archival facility

Investigator Initiated Studies (IIS)

We manage IIS from Individual Investigators, Institutions, Academic groups and or collaborative groups and support them end to end for promising medical interventions, data collection and Analysis & Evaluation.

Therapeutic and Sub-Therapeutic Expertise

Graph showing volumes in terms of Disease Classification

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