Ensuring Patient Safety with Precision and Integrity

Expertise in Pharmacovigilance and Drug Safety Monitoring

At Klinforsche Clinical Science, we specialize in providing comprehensive pharmacovigilance services to ensure proper safety evaluation of pharmaceutical products. Our expert team is dedicated to deliver high-quality drug safety monitoring and risk management solutions.

Pharmacovigilance Services

Case Processing

Comprehensive management of adverse event data including collection, entry, medical evaluation, and timely reporting to regulatory authorities.

Signal Detection

Proper data mining and scientific evaluation of safety signals of medical products by our experts.

Benefit-Risk Management

Creating and executing comprehensive risk management strategies to address potential hazards linked to medicinal products.

Aggregate Reports

Preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) and other aggregate reports by our skilled team.

Literature Searches and Surveillance

Systematic monitoring of scientific publications and databases to identify and analyze safety-related information for pharmaceuticals.

Safety Management Plan Development

Tailoring comprehensive safety protocols to meet specific clinical trial requirements and ensure participant protection.

DSMB/DMC Management

Efficient coordination and support for Data Safety Monitoring Boards and Data Monitoring Committees in clinical trials.

Regulatory Compliance

Ensuring all pharmacovigilance activities meet the stringent standards set by regulatory authorities worldwide.

Our Services Include

Case Processing- Collection, data entry, medical assessment and reporting

Global ICSR and aggregate report submission expertise

Signal Detection

Utilizing advanced analytics to detect, assess, and manage signals throughout the product lifecycle.

Aggregate report preparation- PSUR, DSUR etc.

Benefit-Risk Management

Development and implementation of risk management plans to mitigate potential risks associated with pharmaceutical products.

Safety Management Plan depending on clinical trial requirement

DSMB/DMC management

Literature searches and Surveillance

Regulatory Compliance: Ensuring all pharmacovigilance activities meet the stringent standards set by regulatory authorities worldwide.