The global Life Sciences industry is transforming rapidly, and the tremendous growth over the last decade in clinical trials has attracted government scrutiny around the veracity, accuracy and transparency of clinical trial data.
A dynamically changing clinical, regulatory, and business landscape is forcing biopharmaceutical manufacturers, medical device companies and contract research organizations to adapt traditional research and development (R&D), pricing, supply chain, and commercial models
Value-based payment contracts while still in their infancy, are structured according to a shared savings model. Shared savings arrangements differ, but in general they incentivize providers to reduce spending for a defined patient population by offering them a percentage of any net savings they realize.
The Medicare Shared Savings Program is the most well-known and standardized example of this new model. Governments and other payors are also instituting price controls and increasing their use of generics and biosimilars to contain drug and device costs.
The FDA and EMA have left no doubt that the December 2016 deadline for CDISC standards compliance is a serious one as well as a growing list of regulatory requirements and expectations that are imposing new challenges on the sector. – after which non-conforming drug submissions will be rejected.
So it’s time for life sciences companies to move from a state of awareness to one of action, something they can’t do without a firm and clear plan for bringing clinical study data into line. A growing list of regulatory requirements and expectations are imposing new challenges on the sector.
Currently, transparency can be broken into two segments: transparency of clinical research data, and transparency of payments made by life sciences companies to health care professionals (HCPs) and institutions.
With the finalization of EMA Policy 0070 in March 2016, the long awaited expectation of anonymizing individual patient-level data and study reports is now a required part of the clinical trial process.
While the policy document goes into considerable detail in certain areas, it also leaves room for interpretation in others. At the same time, it is up to manufacturers to determine the best approach to delivering anonymized content in practice.
Slowing revenue growth in developed countries is prompting entry and expansion in new, up-and-coming markets. The conduct of clinical trials has increasingly become globalized and expanded well beyond the traditional regions of North America and Western Europe.
Global trials now typically include centers based in Asia, Central and Eastern Europe, Central and South America and the Middle East. This globalization is the result of a number of significant advantages over limiting trials to traditional locations. These advantages include access to greater numbers of patients and hence faster recruitment, brand exposure to more markets, cost efficiencies and access to patient populations to facilitate marketing approvals in various countries.
Modernizing existing infrastructure and processes requires significant investments of time, resources and budget, and wise investments result in reduced total costs, higher quality results and flexible approaches to future modernization activities.
The d-Wise Life Sciences Practice has been providing Clinical Advisory and Modernization Services to our clients for over a decade. Our consultants routinely work with Life Science organizations just like yours, to adopt a progressive and comprehensive approach to modernizing your clinical trial solutions and processes. We work with you to identify existing business problems – systems, processes, architecture, etc. – that are inhibiting your ability to achieve your clinical research goals. We then enable you to reach those goals by modernizing your software and solutions, business processes, and infrastructure.
Our end-to-end expertise and assessment services encompass business process and change management; data and metadata-driven strategies; and vendor-agnostic infrastructure and technology assessments.