India
Emerald Clinical in India is capable of offering the entire spectrum of clinical development services, including project management, clinical data management and project operations.
Emerald Clinical’s long history in the sub‑continent includes extensive experience working in both urban and rural areas of India. With more than 500 sites and 1.4 billion people – including a vast treatment-naïve population and clinical development cost far lower than Western countries – India is an ideal destination for clinical trials. Many sites also have state‑of‑the‑art facilities and well‑trained clinical research professionals with excellent English skills.
India’s regulatory environment has improved significantly over the last few years. The New Drugs Clinical Trial Rules (NDCT) formalized in 2019 are balanced and well received by the global research community. Many of the sites are experienced and understand the requirements of conducting international clinical trials. Sites have been inspected by USFDA, MHRA, EMEA and other regulatory agencies in the past which demonstrates that quality clinical trials are being conducted in India and data from India are being accepted by regulatory authorities. These elements make India a highly attractive destination for clinical trials.
India has been conducting global studies for more than 30 years. Several guidelines provide the framework for clinical trial conduct in India, such as the Indian Good Clinical Practice, the Indian Council of Medical Research ethical guidelines and clinical trial‑related drug laws (NDCT 2019).
The cost to conduct a trial in India is estimated to be 40-70% lower compared to the United States or European Union.
What are the benefits of conducting clinical trials in India?
- The favorable and well‑balanced regulatory environment
- A genetically diverse population pool of over 1.4 billion has patients with unmet medical needs.
- Standard of care is aligned to Western medical practice which enables easier global clinical trial conduct and thereby better adherence to protocol, patient safety and compliance.
- Well‑trained medical community with thousands of English‑speaking investigators trained in western countries and actively collaborating with international medical societies.
- Over 700,000 specialty hospital beds from 221 medical colleges with English‑speaking medical and paramedical health professionals
- The rising burden of non‑communicable diseases in therapy areas such as cancer, cardiovascular diseases, diabetes, chronic respiratory diseases, mental health, neurological disorders, and chronic kidney disease.
- India’s contribution to global clinical trials enables shorter recruitment timelines and equitable contribution to global recruitment strategy.
- Lower trial costs than most other global regions.
- English‑speaking life sciences workforce aligned to global work practices ensures comprehendible and seamless communication with different global clinical trial stakeholders.