Clinical Research

Clinical Trial Management

Clinical Research is a systematic study of new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic), or adverse Effects with the objective of determining the safety and efficacy of the new drug.

Indian clinical trials market size was valued at USD 1.9 Billion in 2021 and is expected to grow at a CAGR of 8.2% over the forecast period. Globalization of clinical trials, growing disease variation and prevalence, and increasing research and development promoting outsourcing are the key factors estimated to drive market growth.

The government of India is taking active initiatives to improve its R&D activities, which is expected to promote the growth of the market. Apart from this, in October 2021, the Department of Pharmaceuticals (India) proposed a new policy to reduce the time required for the approval of innovative products by at least 50% within the next two years, to improve the R&D activities in the country.

Such initiatives are anticipated to further propel the growth of the market. In 2021, India approved over 100 global clinical trials, the highest number since 2013. Covid hit 2020 also saw 87 global clinical trials in India. These were 95 in 2019, 76 in 2018, and 71 in 2017.

India enacted the new drug and clinical trials (NDCT) rule in March 2019. India’s clinical trials market size is expected to reach $ 3.15 billion by 2025 with a compounded annual growth rate of 8.7%, according to various estimates. The Indian clinical trial market size was estimated at $1.9 billion in 2019 and just over $2 billon in 2020.

Clinical Data Management

India has developed into a superpower for Information Technology and has become a major hub for pharmaceutical and biotech manufacturing and contract research.

The outsourcing business in various other segments is also exhibiting promise. Clinical trial data management and statistical analysis is one such area which is growing rapidly, accompanied by a variety of players entering into different models of this business.

Medical Writing

Medical writing is the activity of producing scientific documentation by a specialized writer.

The medical writer typically is not one of the scientists or doctors who perform the research. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use, and other medical information.

The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.

Medical writing as a function became established in the pharmaceutical world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely.

A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval.

This drives demand for well-written, standards-compliant documents that science professionals can read and understand easily and quickly.

Regulatory affairs

Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.

The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:

1. pharmaceuticals,
2. Medical devices,
3. In vitro diagnostics,
4. Biologics and biotechnology

The regulatory professional’s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising, and post-market surveillance.