By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
Data is everywhere, and its importance in today’s world cannot be overstated. Oracle president Mark Hurd recently noted there will be as much data created in the next year and a half as has been created in the entire history of the planet. Add to that the fact that data is also now coming in from many sources that didn’t exist in the past. According to Hurd, there are currently 9 billion devices connected to the Internet, a number that may reach 50 billion by the end of the decade. This will create an absolute explosion of data that businesses, including those in the life sciences, will have to manage. We know going in that a lot of that data will be worthless. Therefore, it will be incumbent upon companies to discern the valuable data from the noise.
Having data is just one part of the equation. Understanding it and properly analyzing it is another. Jeff Baker, deputy director, Office of Biotechnology Products, CDER at the FDA, recently said, “There’s a big difference between data analysis and knowledge management. Data analysis yields information; knowledge management tells you what to do with this information. Business hasn’t learned to link knowledge management to risk.” His point is clear: Simply having access to large amounts of data doesn’t do us a lot of good if we don’t know what to do with it.
Having an abundance of data can be very helpful (provided we know how to properly analyze it) when selecting the right partners to trust with your outsourced clinical trials and manufacturing. For that information, we at Life Science Leader turn to our partners at Nice Insight.
We all know the relationship between pharma and CROs is changing. Some firms still use the transactional approach of outsourcing a specific aspect of a clinical trial to a specific vendor. Others have jumped on the strategic relationship model where both the vendor and the CRO have a larger investment in their respective partners. Of course, this latter model will place considerably more importance on the process of selecting a partner. Still other companies will use a combination of the approaches, depending on the study under consideration. By looking at
available data on what companies are doing, as well as why they are doing it, outsourcers will be able to make better decisions regarding what approach is best for them.
Once you have landed on the right course of action, you still have to select a partner. Here again, data, especially data collected from your peers, can greatly simplify the selection process. How do other pharma companies view their service providers when it comes to quality? Timeliness? Cost? Regulatory compliance? This information can be incredibly valuable when it comes to making choices.
Finally, once you have a list of preferred providers, how do you know if anything has changed at that vendor that could change the dynamic of your relationship? Has a recent merger or acquisition affected the CRO’s ability to conduct your study? How would you know this? Timely and accurate data is again the answer. In compiling this issue, Nice Insight meticulously gathered and analyzed the data contained on these pages, and we present it here to assist you in your decision-making process.
I hope you will enjoy this special issue devoted to the pharma/CRO relationship. Andy Dahlem, VP of Lilly Research Laboratories’ (LRL) operations and LRL Europe, once told me, “When I make a deal with a service provider to do the work, it’s my reputation that is at risk. That is not a responsibility I take lightly.” Hopefully after absorbing the information in this issue, you will feel a lot more at ease when putting your own reputation on the line.