Monitoring drug safety

Pepgra has extensive experience in preparing post-market surveillance (PMS) reports. Our PMS experts adhere to guidelines such as the European Medicines Agency (EMA), Food & Drug Administration (FDA), and other local country guidelines.

Extensive Post-Market Surveillance

In recent years, emphasis on legislation in post-market clinical data is becoming increasingly more prevalent. Thus, regulatory agencies have compelled the need for a feedback system specifically to provide early warning of quality problems and require input into corrective and preventive action processes for the manufacturers.

Pepgra CRO helps in advancing public health by detecting and assessing safety indications from available data sources using evidence-based techniques and recommends appropriate regulatory actions such as changes in labelling, Risk Evaluation and Mitigation Strategies (REMS) and communication of relevant safety information. Pepgra CRO with its vast knowledge of pharma industry and impressive in-house capabilities offers their clients high quality and cost-effective services in post-marketing surveillance . Our post-marketing surveillance experts with strong educational background and experience in clinical training offer you effective solutions to mitigate adverse effects of drugs and medical devices. We leverage our state-of-the-art technological infrastructure to transfer the benefits of latest advancements in PMS to our clients.

We collaborate with expert PMS analysts and systems around the world to provide the best of PMS services to our clients. Our scrupulous adherence to global guidelines and best practices in documentation has enabled us to win distinct appreciation from our clients for consistency and professionalism. Our team has well-versed understanding of various guidelines including MEDDEV, and EN ISO. We understand the repercussions of administering drugs or medical devices that are likely to cause serious adverse effects in the patients.

Pepgra CRO organizational philosophy shows zero tolerance to even marginal fluctuations when it comes to maintenance of safety standards and effectiveness of the drug or medical device. Our service in the way of end-to-end complaint management system is very helpful to our clients in addressing issues related to patient outcomes in a cost-effective way. We ensure that all our PMS services conform to GPSP and GVP standards.

At Pepgra CRO, PMS experts undergo continuous scientific training to gain insights into the latest processes, procedures and technological advancements that impact the quality and delivery of PMS services. In addition, Pepgra CRO’s customized learning and development programs prepare our expert team to meet the challenges of technically complex PMS processes. Our team of consultants possess excellent knowledge of engineering, quality assurance, product engineering besides considerable regulatory compliance experience. We make the optimal use of global PMS template in offering PMS services to our clients. Our global network helps us offer to provide services of international standards at reasonable prices. Our blend of highly qualified and trained PMS specialists and sophisticated technological prowess is enabling us to provide effective PMS suggestions and recommendations to our clients.

Comprehensive post-market surveillance

Our PMS services include:

• Case and exposure management.
• Adverse event follow up.
• Medical monitoring & reporting services.
• Post-marketing literature surveillance.
• Marketing clinical studies—before and after cases
• Compliant intake.
• Registration and investigation.
• Product surveillance.
• Complaint management.
• Technical services.
• Regulatory assessment.
• Diagnostic reporting.
• Organizing training
• Complaint analysis.
• Content development and packaging.
• Product analysis.
• Contact centre for patient assistance.
• Physician notification, management.
• Trends and analytics, leadership management, and outreach programs to increase patient pool.
• Imparting training (store, stream, deliver content) as a service.
• Key opinion leader management as a service.
• Content development and packaging.
• Unique outreach platforms to increase patient pool.