Friday, December 20, 2013

Indegene® and DrugLogic® to offer Full Lifecycle Drug Monitoring (FLDM)

Indegene® and DrugLogic® to offer Full Lifecycle Drug Monitoring (FLDM)
Indegene (www.indegene.com) and DrugLogic (www.druglogic.com) announced a joint offering for pharmaceutical companies and healthcare organizations that would combine the extensive medical expertise of Indegene with the sophisticated Big-Data analysis capabilities of DrugLogic’s Qscan®. This knowledge and expertise-based offering combines sophisticated evidence-based statistical results, with experience-based physician monitoring, to help decipher a drug’s clinical behavior and detect signals related to its safety and interactions with other factors.

Today, Clinical Development, Regulatory and Safety divisions within pharmaceutical and biotechnology companies face rapidly increasing expectations and many new challenges to detect and characterize the evolving safety profile of their products. This expanding challenge is driven by the rapidly expanding volume of data (“big-data”) as well as the increasing complexity of medication regimens.  Never has the need for integrated and insightful expert analysis and interpretation been greater.  Traditionally, consultants to drug companies have largely relied on either medical teams to assess drug risk, or statisticians with data and tools to augment in-house teams. “Drug monitoring requires the integration of medical review coupled with sophisticated signaling and analytic systems,” said Dr. Sheila Weiss, Chief Science Officer of DrugLogic. “By joining together we can rapidly deploy expert teams with immediate access to data and the analytic capabilities that drug safety requires.”

The joint solution draws synergistically upon the expertise and experience of Indegene’s team of 400+ in-house physicians and the 14+ years of application legacy of Drug Logic’s Qscan. The Indegene-DrugLogic team will offer the best of both approaches during drug discovery, through clinical trials, and post-launch. The team will provide speedy and efficient pharmacovigilance based on many years of experience, and models to address challenging questions. The solution will use the analytical capabilities of DrugLogic’s Qscan—an application that has been used with over 12 different databases and billions of records—and extensive knowledge and expertise of Indegene’s TrialPedia™ platform—the most comprehensive clinical trial analytics platform with over 200,000 trials across 200+ clinical indications. The team will adapt the best data from adverse events, claims, medical records and prescription monitoring programs that are both publically and privately available. “By putting massive amounts of data and insightful statistics in the hands of clinical experts, we will quickly, accurately, and efficiently shorten the time to understand and react to a drug’s behavior and safety profile,” said Dr. Rajesh Nair, President - Indegene.

DrugLogic’s Qscan is a platform that has been applied to several different types of databases. These include the FAERS, VAERS, and WHO databases. It has also been applied to larger medical record and claims databases, such as Medicare, Medicaid, private, and de-identified medical data. Victor Gogolak, DrugLogic’s founder and President, stated, “with not just a few, but a deep bench of hundreds of trained physicians, the power of analytics can be used with speed and confidence. Without the interpretive experience, statistics can be bewildering, or even misleading. With just one database, there is danger of systematic biases that can be mitigated by viewing drug behavior from multiple angles.”

“Indegene’s collaboration with DrugLogic is testament to our philosophy of continually combining scientific expertise with innovative technology to solve pressing challenges in the pharmaceutical and healthcare industry. We believe our existing and future clients will benefit tremendously from this approach.”, Dr. Nair summarized.

About Indegene
Indegene is a leading provider of Clinical, Commercial and Marketing solutions to global pharmaceutical and healthcare organizations. We partner with clients to drive both productivity and revenues by delivering better patient outcomes; optimizing cost; enhancing R&D agility and improving sales and marketing effectiveness. We apply deep scientific knowledge, flexible delivery models, proprietary technology, and a client-centric approach to drive transformational initiatives.

With offices in US, UK, China, India, and Australia, Indegene can partner globally with clients, leverage a global talent pool of clinicians, technologists, creative specialists, domain experts, business process specialists, deploy global infrastructure assets, and harness global healthcare knowledge to solve client challenges.


About DrugLogic®, Inc.

DrugLogic®, Inc. specializes in developing analytical tools and enterprise process support systems for managing risks related to drug safety issues.  DrugLogic designs, develops and delivers products that provide the latest innovations and state-of-the art solutions in support of patient and drug safety surveillance practices for Health Care and Pharmaceutical enterprises. Its proprietary Qscan® product monitors both patient, adverse event, claims, outcomes and publicly available data sources. For more information, visit www.druglogic.com.