Galt Introduces Surveillance Services Division; Dr. John Clark to Lead Company's New Signaling and PSUR Services for Faster, More Efficient Surveillance of Public Health Safety Data.

Business/Technology Editors & Health/Medical Writers

STERLING, Va.--(BW HealthWire)--July 22, 2002

Galt Associates, Inc., provider of drug safety and marketing software and services, unveiled today its Surveillance Services Division, which offers outsourced pharmacovigilance services, including signal detection and evaluation services, Periodic Safety Update Report (PSUR) services, and adverse event coding services. Also announced today is Galt's appointment of Dr. John Clark, who joins the Galt executive team as Vice President of this division. Dr. Clark will oversee the new services, which provide surveillance, reporting and analysis of safety data and associated documentation. Galt's new services enable pharmaceutical companies to meet regulatory requirements and deadlines, allow staff to be more productive - and ultimately help drug companies provide safer, better therapies to the public.

Regulatory agencies worldwide continue to increase pharmaceutical companies' requirements for tracking, reporting and documenting all adverse events related to a particular drug or therapy. Adverse events associated with all drugs - whether newly introduced or having been on the market for 10 years - must be tracked and reported. Galt Surveillance Services Division uses proprietary analytic tools and formalized SOPs to identify potential safety issues and differentiation opportunities, and generate critical supporting documentation. Galt's dsSignal and PSUR Services enable pharmaceutical companies to more rapidly and efficiently put safety issues in an appropriate concept and make critical marketing decisions about their products.

"I'm excited to be part of an organization that combines state of the art software with clinical and surveillance know-how and delivers it to clients in a turnkey service model. Our mission is to invest in the best tools and techniques so that we can deliver the most efficient and timely services to our clients in a rapidly changing risk management environment," said Dr. John Clark. "By leveraging our proprietary technology, medical expertise and utilizing standard procedures and documentation, Galt's new Surveillance Services provide pharmaceutical firms with a cost-effective alternative to in-house resources."

Galt's Surveillance Services Division Includes:

dsSignal -A client-directed service that carries out systematic signal detection on either company or multi-product databases. Signal detection is a process whereby collections of adverse event (AE) reports are examined to discover relationships between products and AEs of potential interest. Galt's dsSignal is designed to provide a product-specific solution for this need. dsSignal offers many advantages:

-- It can be used with company post-marketing product databases and/or the FDA's Freedom of Information data.

-- Both traditional signaling and screening procedures are included, as well as newer database methods such as Bayesian data mining.

-- It is structured to provide regulatory documentation, meet constrained timelines, and help manufacturers stay in compliance with regulatory standards.

PSUR Service - Galt has developed a flexible, efficient, documented methodology for compiling PSURs. PSURs are comprehensive worldwide safety summaries of marketed products that are forwarded periodically to regulatory agencies in most major markets. As the role of the PSUR has increasingly become the central focus of product surveillance, demands have been placed on companies to quickly analyze and synthesize ever-larger amounts of safety data from multiple sources. PSURs offer many benefits to pharmaceutical companies:

-- A single report can satisfy most post-marketing periodic reporting requirements worldwide.

-- Safety regulatory discussions can be easily updated.

-- Signal detection and evaluation activities can be documented and explained.

-- Standard framework for presenting exposure data, safety issues, and labeling initiatives increases efficiency and reduces risk.

Case Management Service - Galt's surveillance group offers several integrated software/personnel solutions for safety-related projects. The Galt post-marketing MedDRA recoding service bundles Galt's hosted dsNavigator software together with process design, recoding expertise and project management. Galt's clinical MedDRA recoding service allows companies to quickly accomplish outsourced recoding projects that meet regulatory submission timelines. The Galt process design/needs assessment service brings the company's pharmacovigilance expertise, software products, and informatics assessment skills together to devise compliant and efficient workflows. The Galt Case Management service brings value to pharmacovigilance departments by emphasizing key values:

-- Process simplification--the multiple components of a large safety project can be coordinated through a single vendor.

-- Compatibility--Galt's familiarity with pharmacovigilance systems and processes lead to compatible and workable designs.

-- Client-centeredness--all Galt services begin and end with a focus on both company and specific product needs.

-- Future orientation--solutions are built with important trends, like risk management and communication, in mind.

As the lead taking these services to market, Dr. John Clark joins Galt with more than 15 years of experience in the fields of pharmaceutical product safety and development. In 1987 Dr. Clark joined the US Food and Drug Administration as a medical epidemiologist and safety analyst. Since 1990 he has worked for several pharmaceutical companies, large and small, during which he worked on projects pertaining to product safety, marketing, drug development, and managed care. In addition to several chapters in books, Dr. Clark has written articles, abstracts, letters, and editorials for medical and industry journals, including the Annals of Internal Medicine, American Journal of Medicine, New England Journal of Medicine, and Epidemiologic Reviews. Dr. Clark holds a BS in Pharmacy from the University of Wyoming, an MD degree from University of Colorado, and a public health degree (MSPH) from the University of Utah.

About Galt's Solutions and Services

Galt partners with pharmaceutical clients in the development and execution of benefit-risk programs to help them accelerate adoption of new blockbuster products. The lifecycle benefit-risk programs are a formalization of the research services Galt has offered its clients over the past seven years. Galt's software products and surveillance services enable clients around the world to easily adapt to current and upcoming global regulations for electronically submitting adverse drug reactions. For more information about Galt, visit DrugSafety.com, or call Liz Allan, Director of Marketing Communications at 703-433-6104.