Clinical R&D on the Move Towards India

Rajendra Jani

Dr. Rajendra Jani, Senior Vice President at Zydus Cadila, shares his insights with Pharma IQ, about current trends in the global clinical market, the shift towards clinical R&D in India and how to improve the efficacy and efficiency of clinical trials.

How do you think the global clinical trials landscape has changed in recent years?

  1. Higher attrition of potential candidates in various phases of drug development
  2. Stringent regulatory requirements and
  3. Recent withdrawal of some marketed new drugs due to various issues
  4. Paucity of new drugs

India is one of the hottest and favored destinations for clinical research outsourcing and conducting global clinical trials, what do you think are the key attributes that are drawing so many pharmaceutical companies to India?

List could be exhaustive, but growth drivers are-

  1. Qualified English speaking manpower
  2. Global medical practices
  3. Medical infrastructure
  4. Diverse, treatment naïve Patient pool
  5. Globally acceptable regulatory environment
  6. Consistent high quality
  7. On time delivery

Speeding up the trial process is a goal for many pharmaceutical companies, what would be your top 3 tips for increasing efficiency?

  1. Due diligence
  2. Project management: Taking into account all possible risks and options after proper understanding of the disease, drug, clinical practices and patients’ and investigators’ psychology
  3. Strong follow-up and execution projects

How do you ensure you don’t lose quality when accelerating clinical trials?

  1. Awareness of global standards among all stakeholders
  2. Monitoring
  3. Stringent quality control (QC) and quality assurance (QA)

How is the industry seeking to address challenges like clinical data security?

Through security enabled IT technology, strong standard operating procedures and promotion of ethics in practice.

What technologies are pharmaceutical companies employing to analyse and improve the efficiency and effectiveness of their clinical trials? 

Various technologies are employed for efficient and effective clinical trials such as

  1. Clinical Trial Management System
  2. Business intelligence & analytics
  3. Electronic data capturing
  4. Clinical data management softwares
  5. Electronic Patient Reported outcomes (ePRO)
  6. IVRS
  7. LIMS
  8. Telemetric ECG

I understand you are part of the exclusive speaker panel for Clinical Trials India, taking place in Mumbai from the 7th -8th March 2011, for anyone interesting in attending the event, what will be your key take home message?

Clinical Trials India is an excellent opportunity to understand everything of clinical trial, particularly with Indian perspective; irrespective of whether it is tools technology, best practices, regulatory affairs.