In my previous blog of this 6-part series, Pharma Lifecycle Plagued with Integration and Data Management Challenges (Part II – Research & Development), I discussed the impact of data integration and data management during the R&D phase. After a drug or medical device survives that stage, it enters Clinical, most often where clinical trials take place en route to becoming approved for general use.
As pharmaceutical companies continue to increasingly transfer any or all of their trial-related execution duties to Contract Research Organizations (CROs), there’s a need for CROs and pharmaceutical companies to share data and information before and during a clinical trial. And while the industry estimates it costs between $1.3 and $5.8 billion dollars to bring a drug to market, the industry spends more than $156 million annually simply to support the data transfer between systems and organizations.
As a result of this model, a few challenges exist that must be overcome from the CRO perspective:
- CROs may or may not have systems in place that can effectively translate the data in a way that the sponsors need during the trial or when it’s time to submit data to the FDA
- Both CROs and their pharmaceutical sponsors need a way of integrating and exchanging clinical trial data that gives the sponsor actionable visibility into their data at any point during a trial
Here’s a short whitepaper that discusses the challenges and how to address them – CRO and Sponsor Data Integration and Harmonization.
Also, as clinical trials become larger (including thousands of participants, for instance), being able to flow the clinical trial data in a reasonable timeframe can also be a challenge.
- The inability of many pharmaceutical companies to be able to handle the large amount of trial data has resulted in delayed time to market, compliance failures (HIPAA and CDISC), and increased costs
- Also, the way data is being handled in the industry is far from efficient and is holding some of the bigger players back from realizing larger profits
Companies that conduct clinical trials are just now beginning to leverage the full power of the internet and the cloud. With access to cloud computing, scaling a clinical trial from 2,000 patients to 60,000 becomes a much smaller hurdle.
These problems will only become bigger and more complex with time. I’d be interested to hear your thoughts:
- How have integration and data management challenges affected the Clinical Trials phase for your organization?
- What other clinical trial data issues have you discovered?
- What steps have you taken to overcome these new challenges?
Until next time,
Gary Palgon, VP Healthcare and Life Sciences Solutions