Overview
In the pharmaceuticals and medical device realm, managing the safety profile of products is paramount. Historically, ensuring that a drug or medical device's benefits outweigh its risks has been a significant challenge, requiring comprehensive Risk Evaluation and Mitigation Strategy (REMS) measures. These measures are crucial for mitigating and eliminating risks associated with patient health and safety throughout treatment.
Recognizing the importance of regulatory compliance, HCLTech's Medical Information (MI) department has extensive experience handling REMS programs for top pharmaceutical companies. Our team adheres to regulatory requirements set forth by bodies such as the US Food and Drug Administration (FDA), ensuring fully compliant and efficient outcomes. By implementing these comprehensive REMS measures, HCLTech has revolutionized safety profile management in the industry.
The results were transformative:
Ensuring all relevant parties are registered and informed about the REMS program
Maintaining a timely supply of necessary drugs and non-drug items
Facilitating patient transfers to maintain continuity of care
Coordinating the collection of laboratory samples for analysis
Continuously monitoring clinical and laboratory parameters
