Last week I had the pleasure of hosting a Compliance Week editorial roundtable in Philadelphia to discuss leveraging data management to enable compliance in the life sciences industry. The discussion was lively as usual, and Compliance Week will have in-depth coverage of the discussion in a separate article. Let me report some of my own conclusions here, however, as data management is quickly becoming one of the central concerns for compliance officers.

Brush Up Your IT Knowledge

The most striking aspect of the discussion for me was how well versed the compliance and ethics officers who attended the forum were on IT. Life sciences companies tend to be somewhat ahead of the curve, since their companies are extremely data reliant and because that data is often rather sensitive, but the level of detail that they work at is astonishing.  And it wasn't just that they were able to speak knowledgeably about systems and technology concepts, but they knew the language of IT. They were far more involved in the planning and managing of the systems than I would have imagined.

“You really do need to become somewhat of an IT expert,” said one of the participants. He went on to say that as compliance has become more dependent on sophisticated systems, compliance officers have had to learn the language to communicate with the IT department to be able to convey what they need. Most of the individuals around the table were talking about how to get various siloed systems down to as few as possible and make them compatible with each other so that they could consolidate the data into manageable streams. It's becoming harder and harder to tell where the compliance function stops and IT begins.

Compliance Undertakings Should Add Value

One of the things that the participants reached a consensus on is that if you are going to go through a massive compliance project to satisfy new regulations, you also have to look for ways that it can add value to the business.

A great example is what companies are now doing with the systems they have put in place to satisfy the “sunshine provisions" of the healthcare reform act. Under the regulations, pharmaceutical and medical device companies must disclose any gifts or payments to physicians and teaching hospitals. The expenses, according to roundtable participants, could be as small as a cup of coffee, running to large honorariums and speaking fees. The systems, which the panelists called “aggregate spend” or “agg-spend” for short, are massive and complex.  “Nobody would go through this if they didn't have to,” said one of the participants.

Still, the new systems are rich in intelligence on expense accounts at pharmacy and medical device companies, and most are now using them to review spending patterns and, if possible, to rein in some of that spending. They are comparing the cost of meals in different cities, for example, and also looking at what types of spending produce the best value. In one case, one of the participants said the new agg-spend system set off alarm bells in the C-suite. “Management said, ‘I didn't know we were spending that much money!”

On a side note about the sunshine provisions of healthcare reform, the forum participants expressed universal frustration with how opaque and vague the rules are. At one point, a participant's comment, “until the government comes up with more concrete regulations …” was met with a roar of laughter from everyone at the table.

Data Is About More Than Systems

During the conversation I was also struck with how important the people component is to data management. The groups spent a lot of time talking about how getting the data that they need is so reliant on getting the people on the ground to buy into the importance of it. “They have to have skin in the game,” said one participant. “It's their business.”

Among the top points of the discussion was that while the systems must be planned, configured, and integrated with the right platforms and reporting abilities, they are still only as good as the data that is entered in and the integrity that it is entered with. “We were able to focus more because we had the systems in place, but how confident are we that we are getting clean data from the field?” Panelists agreed that monitoring and audit is essential to improving the quality of the data.

They also agreed that culture and the always important “tone at the top” play a vital role in getting good data. The roundtable participants said that it's important to communicate to the business units and especially to far-flung global offices what data is needed, how it is used, and why it's important. They also agreed that compliance needs to be “pushed out” to the business. “Part of getting that buy-in  is to explain that they own their own compliance; the CCO is only there to monitor,” said one participant.

Those are just a few observations from the discussion. Look for a full write-up in the Nov. 13 issue of Compliance Week.

Next Up…

Compliance Week holds executive forums around the country just about every month, open (at no charge) to in-house compliance, risk, and audit executives looking for a chance to talk shop with your peers. What's on deck in the coming months?

We'll be Dallas on Nov. 27, to talk about those whacky new rules for disclosure of conflict minerals and payments to foreign governments for mining operations. If you want to feel overwhelmed with fellow compliance executives, I can't think of a better place to be.

Next, we will be in Washington D.C. on Dec. 11, hosting a roundtable to discuss the ROI of a strong ethical culture, including the role that communication and training plays in building an effective compliance culture and how to foster that culture across diverse geographic locations in a global company.

Interested? Just e-mail Editor Matt Kelly at matt.kelly@complianceweek.com, and let's talk.