Full Service Flexible CRO:

Our sponsors tell us that the full-service outsourcing model ultimately delivers higher quality results, with the most economical cost possible.

 

Full Range of Integrated Services:

A full-service CRO model helps coordinate and integrate different pieces of the whole pie. CliniRx provides an accountable, flexible, integrated, seamless and efficient platform for result oriented clinical research. This model increases quality and speed while significantly reduces the cost of the whole program.

Introduction

Capabilities Overview:

Well defined SOPs, Scientific Inputs, efficient clinical project management, regulatory leadership are combined to deliver high-quality results for the studies.

Regulatory Affairs

CliniRx provides following services through in-house experts in India and US and through our preferred partners in Europe. The following Services are on offer:

  • Global Regulatory considerations assessments and Clinical Development Plan input
  • Global Regulatory and Scientific Advice strategies and support throughout the development program
  • Global Regulatory Agency and Scientific Advice meeting strategy, preparation of briefing documents, and execution of the regulatory strategies throughout development until approval of the application/dossier
  • Regulatory management through full product life cycle
  • Regulatory strategy and agency communication to obtain first-cycle approvals
  • Technical writing for submissions
  • Regulatory eCTD dossier preparation, publishing and submission of all sequences/amendments and NDA/EU MA applications filings
  • Application filing, review meeting preparation, follow-up in India

Project Management

Experience Flexible yet Highly Disciplined Execution:

CliniRx Project Management optimises unique mix of team structure and preferred partner model to deliver effective results. The preferred partner model leverages best of the training and resource planning. Our dedicated teams are designed to flexibly serve as an extension of Sponsor’s team and provide unparalleled support at every stage of the clinical developmental program.

Quality Assurance

The Quality Assurance department is responsible for implementing quality assurance policies and procedures. By ensuring adherence to protocols, Good Clinical Practice (ICH-GCP) and local/international regulatory guidelines, the clinical Quality Assurance services help ensuring the integrity of clinical trials.

CliniRx provides:

  • Investigative Site Audits
  • Vendor Audits
  • Internal Audits
  • Regulatory Training (GCP)
  • Regulatory Inspection Preparation/Mock Regulatory Inspections

Clinical Monitoring

CliniRx shares the same view as the Sponsor, for the clinical program and has the ability to be as Flexible as possible to monitor the study keeping the best interest of the Sponsor.

Clinical project management and clinical monitoring must adapt to the new complexities that are faced regularly by clinical trials. CliniRx has done so, by developing and implementing quality risk management systems such as Risk Management and Mitigation Plans and regular protocol Evaluations. Active efforts are made by the trained monitoring team to reduce the number of queries to generate precise and meaningful data.

Data Management and BioStats

CliniRx deliver high quality clinical data management to support drug development needs of the Sponsor so that drugs get to the market as quickly as possible. CliniRx provide be spoke solutions tailored to specific requirements and provide real time, faster access to data; meaning faster decisions can be made to keep patients as safe as possible.

CliniRx provide end to end comprehensive clinical data management solutions for Phase II through to post-marketing trials. Our preferred partners (global clinical data management experts) are committed to upholding a standardized, process-driven approach.

Biostatisticians at CliniRx have desire for quality and implement the best approach to a situation/scenario to ensure correct analysis without an over complex process. By using the appropriate tools, our preferred partners are able to demonstrate the efficacy of a drug and present the results in the clearest way possible.

Drug Safety and PVG

CliniRx provides comprehensive drug safety, medical information, medical writing, risk management programs through its preferred vendor.
CliniRx provides the safety database, aggregate reporting and complete clinical safety and medical writing services. We believe that our experienced personnel will be able to assist you not only as a service provider but also as an extension of your current team.
A complete hosted and fully validated ARGUS Safety database, in accordance with 21 CFR Part 11 and EU GMP 5 Regulations, will be provided.
A team of expert medical physicians will be assisting in writing a complete Clinical Study Report (CSR).