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Klinikos

High-quality clinical
research program

The research wing of NephroPlus was set up in the year 2015 with a mission to enhance and collaborate with renal therapeutic partners across the globe and deliver ethical and unbiased clinical trial outcomes. Klinikos provides clinical research services for Pharmaceutical and Biotechnology firms and to academic institutions for research purposes. The vision is to generate high-quality data through the four stages of clinical trials.
Klinikos has always adhered to all norms, scientific, ethical and regulatory, in the conduct of clinical trials. In order to fulfil these requirements on a continual basis, the Clinical Research team functions separately along with internal and external stakeholders.

Klinikos Caliber

  • Large number of centres across India
  • Certified centralised research staff & efficient
    ground level staff
  • Usable data of the largest dialysis patient pool &
    sub-therapeutic areas
  • Research published in peer-reviewed journals

Methodology

Klinikos has an advanced infrastructure suitable for conducting trials with the startup, conduct and close out – archival teams.

Startup Team

Our project management and startup
coordinators support the sponsor or CRO in:

  • Feasibility
  • Identifying and supporting sub-therapeutic areas
  • Clinical Trial Agreements (CTA)
  • Regulatory submissions

Conduct Team

Our project management and conduct
team coordinators provide support in:
  • Patient screening
  • Recruitment plan
  • Investigator training
  • Conducting the study as per the GCP and regulatory requirements
  • Ethics committee submissions and ongoing review and approvals
  • Quality assurance
Our full time clinical research staff ensures planning and
execution of clinical trials within the stipulated timelines.
Close Out – Archival Team
Our project managers and close out coordinators
along with the archival specialists ensure:
  • Systematic close outs
  • Planning according to the sponsor-CRO-regulatory requirements
  • Archival facility

Partnerships

We actively work and collaborate with global healthcare providers to partner and bring efficiencies in dialysis services across the world.

The George Institute
for Global Health

Investigator Initiated
Trials

Jehangir Centre for
Learning

Academic &
Collaborative Groups,
Data Collection and
Evaluation

GSK Pharma

Pharmaceutical
Companies

PPD CRO

Medical Interventions and Clinical Trials

Data Protection and Privacy

A stringent set of Standard Operating Procedures on clinical trials is in place to maintain the security and confidentiality of outcomes covering all essential requirements as per Regulatory and ICH GCP norms.

Clinical Trials

Clinical trials are experiments or observations done in clinical research, generating data on dosage, safety and efficacy. They are conducted only once the approval is received from the health authority/ethics committee in the country where the approval of therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean the therapy is ‘safe’ or effective, only that the trial may be conducted.
NephroPlus has an infrastructure suitable for conduction of the trials with the startup, conduct and close out – archival teams. Our full time clinical research staff ensures planning and execution of clinical trials within the stipulated timelines. NephroPlus has SOPs on Clinical Trial Management and we ensure all the essential requirements as per the Regulatory and ICH GCP norms.

Academic Studies

An academic clinical trial is a clinical trial not funded by pharmaceutical or biotechnology companies for commercial ends but by public-good agencies (usually universities or medical trusts) to advance medicine. These trials are a valuable component of the healthcare system. Our infrastructure is best suitable for the conduction for the academic trials and we ensure quick investigator initiated trial outcomes within favourable budgets and in-house quality data maintenance. Our in-house data maintenance helps extensively in retrospective analysis.

Ethics Committee

For the purpose of the Rule 122DD, an Ethics Committee is a committee, composed of medical, scientific, non-medical and non-scientific members who ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial. We have our own Ethics Committee – Nephrocare Institutional Ethics Committee (ECR/1532/Inst/TG/2021) to hasten the approval processes and trials start-up. Ethics Committee SOPs are standardised and the process is use-friendly. Ethics Committee administration and effective timely delivery for reviews and submission processes. Quick quality checks as per ICMR and CDSCO. Less waiting time for reviews and approvals.

Become A Clinical Research Expert

NephroPlus in partnership with JCL (Jehangir Centre for Learning), one of the leading academic research arms of Jehangir Hospital, India, has developed a Certificate Program in Clinical Research.

Eligibility

  • Graduate in Life-Sciences
  • Non-Graduate Science Stream

What will you learn?

  • Introduction to Clinical Research
  • Evolution of GCP
  • Investigator training
  • Principles of GCP + Practical Application + Case Studies
  • Phases of clinical trials and drug development process
  • Medical terminologies in Clinical Research
  • Drug & Cosmetic Act 2019
  • Informed consent, elements and documentation
  • Essential documents in Clinical Research
  • Source documentation
  • Overview of trial design and protocol writing
  • AE/SAE reporting
  • Fundamentals of clinical data management
  • Fundamentals of pharmacovigilance

Course Duration

6 Months

For more information about enrollment into the Clinical Research Certificate Program:

Please reach out to our Clinical Research Head – Dr. Vidya Joshi at vidya_j@nephroplus.com or our Clinical Research Team at prasanna_t@nephroplus.com.

Original Articles in
Peer-Reviewed Journals

Peer review is the essential part for maintaining considerable standard in publishing. This brings out the best possible scientific information from the potential authors and researcher scholars. At NephroPlus, our researchers work towards creating original articles for peer reviewed journals.
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List of abstracts presented in Conference / Symposia / Seminars

Explore our best works presented at some of the most prestigious medical events across the globe.
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