INSIGHTS INTO DRUG SAFETY

Uniquely focused on drug safety, Sentrx has a view of pharmacovigilance trends in large and small biopharmaceutical companies. Here's what we see:

International Reporting
In the past, only large global pharmaceutical companies marketed products in multiple countries and needed to report Individual Case Safety Reports (ICSRs) internationally. Today, small companies with just a single product are taking their drugs into as many countries as possible. With the European Medicines Agency (EMEA) requiring electronic reporting of ICSRs by November 2005, smaller companies need the same high-end information technology solutions that large global companies operate to remain in compliance with these new regulations that follow ICH standards. The financial burden is large in relation to revenue, but hosted solutions can reduce the impact.

Read the European Directive establishing the requirements for electronic reporting
Read more on the costs of implementing and maintaining a Drug Safety System

Clinical Trial Events
The Prescription Drug User Fee Act (PDUFA) III has had a direct influence on the collection and analysis of safety data during clinical trials. The Act recommends that a risk management plan be submitted with the pre-NDA meeting package. Thus, companies can no longer wait until the last patient to analyze serious adverse events (SAEs). SAE collection must be centralized and standardized across company and country borders so that ongoing analyses can be performed. A risk management plan that reflects the most current data can then be prepared without delaying the New Drug Application.

Read the Next Generation Pharmaceutical article on safety reporting in clinical trials

Informing investigators of clinical trial events also requires a centralized approach. Across the ICH regions, guidelines vary for reporting suspected unexpected serious adverse events (SUSARs) to investigators. Factors such as the reporting country, the licensing status of the study drug, and the classification of the event affect reportability and timeframes. A standardized process must be implemented in global trials with centralized rules for reporting to investigators.

Read the Applied Clinical Trials artical on SAE reporting to investigators in ICH regions

The Partnering Process
Selecting a services vendor is an important process. Unlike a product purchase, a contract with a company to provide services is a commitment to a long-term, multi-faceted relationship. Sponsors should ensure that the team the vendor will support has several opportunities to interact with the leading candidate's team to assess interpersonal styles.

At the same time, the vendor selection process must be efficient, as sponsors often have a pressing need for the service they are seeking. Their team should determine the criteria for evaluation and implement a methodology that allows them to evaluate vendors against those criteria expediently.

Read the PharmaVOICE article on the partnering process from a sponsor's viewpoint