A recent increase in R&D across biotech and pharma companies has led to a booming CRO market, expected to nearly double in a six-year period from $34 billion in 2014 to $59.42 billion in 2020, according to Zion Research. With this market growth, there has been a significant rise in specialized CROs along with an upsurge in mergers and acquisitions as firms attempt to solidify their position in the industry.  As reported by InVentiv, one key merger that took place last year was between Quintiles and IMS Health, who came together in a massive $19 billion megamerger, and now INC and inVentiv are looking to follow suit, combining into one new major company that will, according to the pair, make it the second largest biopharmaceutical outsourcing provider in the world. Increased competition is forcing CROs to think about how they set themselves apart from the growing number of organizations supporting clinical research.

Maintaining focus on recruiting, developing, and retaining top performing sites
The recent spike in clinical development programs has resulted in a disparity between the growing number of studies and sites willing to conduct studies. According to CenterWatch, the average number of new studies initiated by the 60 highest volume sites in the U.S. and Canada fell by 85%. This gap has made it even more difficult for CROs to attract and retain top performing sites that deliver the patient base and support the protocol.

A recent survey conducted in partnership with the Society for Clinical Research Sites (SCRS) highlighted key issues around financial operations, processes and systems at sites as well as key issues around patient reimbursements which impact study participation and completion. The study found that more than three-quarters of sites reported that reimbursement timelines have an impact on their ability to pay stipends and reimbursements to patients. Slow payments make it difficult for studies to operate efficiently as they affect all parties involved from site to patient.

The key to CRO success is to understand the issues faced by sites when conducting a study.  Cost and time invested are common pain points.  Start-up costs can reach up to $30,000. While the sponsor ultimately pays this fee, sites oftentimes have to cover these costs upfront due to payment delays.  In addition, it can take upwards of seven months to begin the research between site identification and initiation. Patient recruitment and retention can be a main cause for delays and expenses; as explained by Clinical Leader, approximately 80 percent of clinical trials fail to meet their enrollment timelines, and nearly 50 percent of trial sites enroll only one or zero patients. In addition, patient recruitment activities represent over 25 percent of overall clinical trial costs.

The issue of cost and time goes further than trial start-up with sites often being required to pay out of pocket costs throughout the study due to inconsistent payments from Sponsors and CROs. In a study by SCRS, it has been shown that “66% of sites globally reported having less than three months’ worth of operating cash.” Infrequent and inconsistent payments, along with complicated invoicing processes, creates additional stress and increased administrative burden for sites, taking focus away from the research – and can be a major determinative factor in sites taking on new protocols.

Increasingly complex protocols and regulations can also add to the headache, making feasibility, staff training and ongoing support more challenging for sites. In addition, global and rare disease studies come with their own regulatory intricacies on top of the added patient recruitment difficulties.

Gain a competitive edge: Implementing the tools and technology for ongoing site success
With heightened competition, CROs are under more pressure than ever from Sponsors to groom and retain investigative sites. Retaining both sites and patients lies in a CRO’s ability to treat them as valued partners. The way to accomplish this goal is by understanding and addressing the various hurdles faced by sites and patients, ultimately developing trust and loyalty for a long-lasting partnership.

In addressing site issues, CROs should be focused on making processes more efficient, reducing administrative burdens and costs. The path to improved efficiency and cost reduction is through cutting edge technology; implementing a tool that seamlessly integrates into a site’s existing workflows and platforms for a more streamlined process.

Implementing a best-in-class technology solution can reduce administrative burdens in many ways, including the ability to execute payments on a more frequent standardized (30-day) schedule while automating the otherwise complex invoicing procedures. A flexible and robust technology backed by an expert team can also support various global regulations, ensuring compliance for sites around the world.

The growth of clinical research has led to and will continue to drive increased competition among large and small CROs. As a result, the ability to retain top performing sites that can support these studies is critical. Patient retention starts with the site and providing sites with the tools to succeed is key to building loyalty and trust for long-term success. Taking an innovative approach by introducing sites to a unique technology platform that streamlines and automates payment and invoicing processes can be just the way to differentiate your offerings. A more efficient process equals happy sites, which leads to supplementary trials, ultimately developing and strengthening a lasting relationship between the CRO, site and Sponsor.
 

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Dave Espenshade
In his role as Greenphire’s Vice President of CRO Partnerships, Dave leads the efforts to broaden the use of Greenphire’s solution suite among global CRO partners. Greenphire is currently working with eight of the top 10 global CROs and continues to see an increased demand for both its investigator payment solution, eClinicalGPS, and patient reimbursement solution, ClinCard, within this sector.