Pharmaceutical and Medical Device Litigation


ISS has teamed up with PCSglobal to form a joint initiative to enhance our service offerings which include a broad range of scientific legal services for pharmaceutical and medical device product liability cases.
 
PCSglobal is a pharmaceutical, biotechnology and medical device industries consulting company. PCSglobal services include training, education, auditing and syndicated reports, as well as customized and multi-service solutions in safety signaling, surveillance data analyses, risk management programs, and dictionary management.
 

Here is how ISS and PCSglobal can help you win your next Pharmaceutical or Medical Device case:

Expert Witness Identification, Support, and Preparation
Pharmaceutical and medical device cases require experts from a distinct set of medical and scientific disciplines, including toxicology, epidemiology, statistics, regultory, and a variety of medical specialties. Check out our Expert ID services to see how we can connect you to the best witnesses for your case.
 
Strategies for Deposition and Trial
Medical and scientific experts must be integrated successfully into the overall scientific strategy. ISS assists with strategic positioning of defense experts (including report preparation) as well as in challenging plaintiffs’ witnesses in deposition, hearing and trial.
 
Literature Surveillance, Data Management & Storage, and Alert Programs
Effectively tracking and identifying relevant scientific literature can be the key to success in a complex toxic tort case. ISS employs state-of-the-art information technology and skilled personnel to track, compile and characterize all scientific literature critical to the alleged toxic exposure or injury. These studies, once identified, are then put into the appropriate litigation context for integration in the overall litigation strategy.
 
Pre- and Post-Market Safety Analyses
In conjunction with PCS Global, our Safety Signaling services provide cost-effective and proactive Detection, Prioritization and Evaluation of Safety Signals using a full range of signaling methods and algorithms (including Data Mining based on FDA AERS and other datasets, and Time Series Analysis).
 
We can evaluate the full range of pharmacovigilance information that is available for a particular signal, and recommend options for risk minimization.
We also help our clients ensure that signaling and surveillance processes and systems are in place that can support comprehensive Safety Data Analyses, Signal Escalation, Surveillance Document Compilation (e.g., periodic safety update reports [PSURs], development safety update reports [DSURs], periodic adverse drug experience reports [PADERs], safety sections of NDA Annual Reports (ARs), Analyses of Similar Events (AOSEs), and ongoing updates to existing Risk Management Plans (RMPs).
 

CONTACT

David H. Schwartz, Ph.D.
Head of Support to Counsel
Innovative Science Solutions, LLC
67 Park Place East
Morristown, NJ 07059
973.889.1600 x104
John Clark, MD, MSPH
President and CMO
PCSglobal
740 Bethlehem Pike
Flourtown, PA 19031
215.948.3421