Pharmacovigilance and Safety Systems

Services

Full Support to Meet All Your PV Needs

From proof-of-concept through all phases of development, our primary technology platform, Flex Database, allows PV management across all studies. Our team has the ability to provide services on other Safety Database technologies.

Adverse Event Reporting

Timely and accurate reporting of adverse events associated with the biotechnology product to regulatory authorities.

Signal Detection

Continuous monitoring and analysis of safety data to identify potential signals of new or increased risks.

Risk Management Planning

Development and implementation of risk management strategies to minimize or mitigate potential risks associated with the product.

Regulatory Compliance

Ensuring compliance with pharmacovigilance regulations and guidelines set forth by regulatory agencies.

Safety Data Management

Collection, processing, and analysis of safety data from various sources, including clinical trials, post-marketing surveillance, and literature.

Benefit-Risk Assessment

Evaluation of the benefit-risk profile of the biotechnology product based on safety and efficacy data.

Pharmacovigilance Training

Providing training to staff members involved in pharmacovigilance activities to ensure competency and compliance.

Periodic Safety Reporting

Preparation and submission of periodic safety reports, such as Periodic Safety Update Reports (PSURs) or Periodic Benefit-Risk Evaluation Reports (PBRERs), to regulatory authorities.

Explore Our Services:

Outsourcing Models

Pharmacovigilance and Safety Systems

Services

Full Support to Meet All Your PV Needs

Adverse Event Reporting

Adverse Event Reporting

Signal Detection

Signal Detection

Risk Management Planning

Risk Management Planning

Regulatory Compliance

Regulatory Compliance

Safety Data Management

Safety Data Management

Benefit-Risk Assessment

Benefit-Risk Assessment

Pharmacovigilance Training

Pharmacovigilance Training

Periodic Safety Reporting

Periodic Safety Reporting

Functional Service Provision

F.A.S.T.

GxP Auditing