Today’s blog post comes to us from Nathan Waller, Medrio’s Managing Director of EMEA and a former Director of Business Development at a Global CRO.
If you know Medrio – if you’ve interacted with us at industry conferences, perused our site, or spend a good amount of time on this blog – you know that we see something truly noble in clinical research. We often describe contract research organizations (CROs) as contributors to advancements in public health, as the engine driving some of the innovation that can end up saving human lives. We believe this to be true, and we stand by it. But even though the work of a CRO can have major public health significance, these organizations are still, ultimately, service providers. And like any service provider, the immediate goal of delivering satisfaction to their clients – in this case, clinical trial sponsors – is always top of mind.
For contract research organizations, sponsor satisfaction arrives through numerous avenues: shorter study timelines, cost efficiency, data integrity, and more. The eClinical providers vying for their business often position themselves around those first two concerns – we include ourselves in this, as Medrio offers the flexibility and ease of use that allows users to reduce timelines and costs – leaving data integrity, implicitly, as almost a given. But data integrity should figure prominently into eClinical vendor selection at CROs. In my 12 years spent working at a Global CRO before joining Medrio, I took care not to make eClinical decisions based on things like study build time without also giving due consideration to things like query detection and ALCOA assurance. Here are a few reasons why.
1. It’s more than just business – it’s regulatory
When things like study build delays cause timelines to drag on, CROs face dissatisfied sponsor clients. The significance of this is not to be understated – it can result in the loss of what could otherwise be a long and fruitful business relationship. But when it comes to lapses in data quality, it’s not just sponsors that organizations have to answer to. There are major regulatory implications as well, and dubious data quality can land organizations in court.
The nature of the Biotech/ Pharma/ CRO relationship can quickly get complicated: examples abound in which Biotech X runs an R&D program with CRO Y; Biotech X licenses Global Rights to Pharma A, who in turn sub-licenses European rights to Pharma B. And then – only after all this has occurred – the FDA discovers irregularities with the dossier. By this point, the product may already be on the market and benefitting patients. Well, that’s tough. Suddenly at least four companies are under the gun and will have to answer to regulatory authorities, shareholders, and patients. Why risk it?
2. Days and dollars are on the line
Any kind of hangup in a clinical trial – whether it’s during study build, patient recruitment, or any other area – can translate to timeline delays. This, of course, includes hangups that owe to issues with data quality. Query resolution, site performance investigation, and source data verification take time. And while CROs often charge by time and thus may not be particularly rattled by every slowdown, it’s important, for the sake of winning repeat business, to keep timelines in check.
If timeline efficiency isn’t compelling enough, there’s also the cost factor. Time is money in clinical research, after all, and dealing with data quality issues creates additional expenses for CROs. These organizations walk the tightrope between resourcing ahead or behind of the business curve. And when resourcing gets tight, who usually suffers? Money talks, and if tough choices have to be made, often it is the ‘smaller’ sponsor who feels it first. The Product Manager is reassigned. Data Management can’t cope with bogus data. Timelines slip, and with deadlines looming, work is rushed and data entry errors occur. Sound familiar? The Movers and Shakers in the industry want to alleviate the resource problem through enabling tools that sharpen the process. Shouldn’t we all?
3. Protect your reputation
As sponsor-to-CRO outsourcing continues to rise throughout the industry, a lot will ride on what CROs do to stand out from the competition. Will your organization gain a reputation for rapid study timelines, effective patient recruitment campaigns, and high-quality data? This is far preferable to an organization that makes a name for itself as a frequent subject of regulatory audits due to unreliable data quality. Investing in tools and resources that ensure data quality can bolster your ability to attract positive interest from sponsors – and win more business.
CROs are correct to evaluate eClinical software vendors largely based on speed, flexibility, and cost efficiency. Amidst these concerns, however, data integrity is not to be taken for granted. What’s your organization doing to protect your data?