Industry consolidation, shifts in outsourcing responsibilities, increased regulatory scrutiny and loss of public confidence in clinical research are among the factors that have prompted a management and structural re-alignment at US-based contract research organisation MedTrials.

The company, which was set up in 1993 and offers full-service capabilities for Phase I-IV clinical studies, is re-organising into four divisions led by individual vice-presidents, each reporting to MedTrials chief operating officer Brian Morgan. As well as increasing accountability and speeding up decision-making, the new structure will enable the company better to support larger full-service projects while providing for an expansion of training and auditing services, it noted.

Ivana Waller will continue to head up MedTrials’ Business Operations division, while Barbara Richardson will serve as vice-president of the Compliance and Regulatory Affairs division, which will include all of the company’s regulatory consulting, training and auditing services. Bill Sams will be vice-president of the Clinical Operations division, which will oversee monitoring and clinical project management services. Kathy Labowitz, vice-president of the Informatics division, will continue to oversee biostatistics, data management and data services.

As chief scientific officer Robin Newman pointed out, at the moment the majority of MedTrials’ projects are centred in the US and “only a handful…afford us the opportunity to offer the full line of services of which we are capable.” One reason for this, MedTrials believes, is that too much of the company’s most experienced talent has been concentrated in a single department, ie. clinical.

Growing informatics division

Accordingly, MedTrials has been growing its Informatics division over the past year and decided to realign its most senior clinical leadership in a way that would further expand its compliance and regulatory affairs departments, emphasising training and auditing services. “This positions MedTrials to effectively lead larger and broader projects, including projects with more international focus, with strong leaders driving each of our service lines, through leveraging the competencies and experience of our existing management team,” Newman told PharmaTimes Clinical News.

The increased attention to training and compliance reflects the current trend to step up regulatory scrutiny and require effective training and credentialing of research personnel, especially at the site level, she explained. While MedTrials has been an industry leader in the training and development of research personnel over the last two years – in which its focus has begun to shift more towards specialty services such as Data Monitoring Committees – in the last five years the company has also “placed a great deal of emphasis on engaging and developing the strongest monitoring and project management teams necessary. We have done this, however, to some extent, at the expense of continued growth in training and auditing.”

Changing climate

The reorganisation is also in response to an industry environment of “significant project delays and client consolidation, as well as a cultural and regulatory shift,” MedTrials noted. Merger and acquisition activity in the pharmaceutical and medical device sectors over the past few years has been intense,” Newman pointed out. As companies in these circumstances often reduce their financial exposure by cutting back on new research and development, the outcome can be “a dicey situation for the CRO supporting them.”

Mergers also tend to result in all current contracts and projects being revamped, which demands that “the best talent in our company be able to cover a larger variety of service lines and be in place to respond authoritatively to client requests and needs, in an often unsettled and restructuring client organisation,” she commented.

The cultural and regulatory shift stems from “the general public’s crisis of trust in the commercial research arena,”, Newman added. “While much of this is undeserved, there are some significant cases where the public’s reaction is completely understandable … CROs and manufacturers must put even more stringent quality controls and human research subject protections in place, and we have to earn that trust back.”

For the most part this is all to the good, MedTrials believes. “Studies are being designed smarter, and companies are more carefully crafting comprehensive research programmes that explicitly contain training and quality assurance components,” Newman said. A more damaging trend, though, has been a tendency for sponsor companies to move vendor selection away from the clinical project teams and into the business department.

“We spent many years developing excellent relationships with the clinical and R&D managers in our client companies and enjoyed a huge amount of repeat business based upon excellent work,” Newman explained. “Removing decision-making power from these managers has forced us to restart our relationship-building in some instances.”

It has also created a trend for outsourcing departments to select only a couple of CRO service providers. “For a company with global trials, a specialty company like MedTrials has some difficulty getting through the screening process to have access to those sponsor managers who could most benefit from our experience and service capabilities,” Newman observed.

Linking up

One strategic response has been to link up with a number of like-minded middle-sized CROs to form the ClinTrust Global Alliance, with a tag-line of “local know-how, global reach.” The rationale is that, rather than trying to be “everything to everyone,” it makes more sense to stress that the best monitoring and project management in a global environment require local expertise. “Recent trends in CRO selection have convinced us that it is time to invigorate and grow this alliance, and we are working on that,” Newman added.

MedTrials is also playing up its credentials as a woman-owned business. “Last year we completed the process of obtaining a certification as a Women's Business Enterprise, and we are finding that the outsourcing managers in larger sponsor companies are responding extremely well to this certification,” Newman said.