Drug Safety Alliance (DSA) | Drug Safety & Pharmacovigilance Services | We maintain product viability and longevity by providing industry-standard, FDA and ICH-regulated services.

	Introduction

	Medical Writing

	Risk Management

	Signal Detection Services

	Risk Assessment and Evaluation

Medical Services

SIGNAL DETECTION SERVICES

DSA’s risk management strategy complies with current regulation and guidance and is customizable to conform to client need. Our range of risk management services includes:

Traditional and automated signal detection (data mining)
Trend analysis
Risk Management Plan development
Pharmacovigilance Plan development
Product label review
Risk communication materials

DSA’s new model for Safety Signal Detection is proactive by using the traditional methods combined with an advanced data mining tool from Phase Forward’s Lincoln Technologies, WebVDME™. This allows DSA to explore any potential signal using the latest technology combined with DSA’s vast safety experience. Proactive pharmacovigilance has become of paramount importance to facilitate risk management activities.

DSA’s proactive PV efforts include:

Ongoing review of safety information for signal detection and trend analysis
Interpreting signals and performing benefit risk assessments
Directing pharmacovigilance activities for safety evaluations such as literature searches, reporting rate calculations, developing a case series or performing data mining
Offer suggestions for pharmacoepidemiology studies, registries and surveys when necessary
Responding to safety queries and audits
Response to medical inquiries from regulatory authorities
Rendering assistance to clients during regulatory audits

The use of proactive signal detection can provide your company with rapid identification of potential escalating risks which, in turn, improves public health standards, protects your valuable product assets and generates overall cost efficiencies.