With the cost of taking a drug to the market steadily increasing, there is a burning need to follow a lean approach toward drug development and deliver high quality clinical data that makes decision making faster. However, the increasing complexities and costs associated with the conduct of clinical trials continue to pose numerous challenges:
- Varying regulatory requirements and timelines across geographies
- Data coming in from multiple sites and sources and the need to drive standardization and seamless interoperability of the same
- Adapting to ongoing changes in technology and platforms, and yet ensuring that the highest levels of data security and privacy are maintained
Thus, pharmaceutical companies, today, seek partners who can provide technology capability to consolidate all their data and a platform that allows seamless interoperability to minimize the duplication of efforts and enhance data integrity.
The recent withdrawals of many blockbuster drugs means that drug safety has become a critical activity in the clinical development programs of pharmaceutical companies. Regulations on safety monitoring have become stringent and are periodically revised. Therefore, pharmaceutical companies need to maintain a competitive advantage while adhering to stringent regulatory norms and drive business agility through the harmonization of regulations and tightening of processes in the drug development and safety process.
The emphasis around drug safety is shifting toward a complex understanding of the benefits of a drug compared to the risks of taking it. Increasingly, pharmaceutical companies will be required to demonstrate the risk benefit analysis of drugs they market. In the past few years, organizations have chosen to work with partners who delivered discrete processes within the drug safety cycle. Increasingly, organizations are seeking to depend on partners to deliver the entire drug safety process so that the objectives like increased regulatory compliance, safety data analytics and early signal detection can be executed efficiently and effectively.
This collection has a great combination of articles from industry subject matter experts, customers and research.
VK Raman, Global Head, TCS’ BPO Solutions, sets the tone in his editorial with a perspective on the evolving world of drug development and drug safety.
Alex Drissen, F Hoffman Roche and Vita Marie Petrik, AstraZeneca, discuss their engagement with TCS for their critical business needs and highlight the benefits they have derived from working with us.
Dr. Nimita Limaye, VP Biometrics and Medical Writing, TCS’ BPO Solutions, discusses how India is at the forefront of strategic partnerships in clinical data management, biostatistics and medical writing. She also engages Dr. David Clemow of Eli Lilly and Halle Gawrylewski of Janssen in a debate over the core competencies of a medical writer.
Dr. Neha Achrekar, Consultant, TCS, writes about the importance and the challenges of drug safety for pharmaceutical companies.
Enjoy the read.