Stacy Surensky, CPC, Director CDM, PROMETRIKA, LLC
A small biopharmaceutical company with big aspirations and unlimited potential was not getting the personalized attention that they expected and deserved from their large CRO. Instead, their needs often took a backseat to the needs of larger organizations, which, in some cases, led to frustrating delays.
When the CRO did focus on their studies, it was unable or unwilling to accommodate requests for things like customized reports and specialized processes. In PROMETRIKA, they found a CRO that shared its views on collaboration, and served more as an engaged partner than a disinterested service provider.
A Company Shaped by Patient Needs
Like many biopharmaceutical companies, their business is shaped by the needs of the patients for whom its drugs are developed. Whether the team is creating new medicines or addressing the equally-critical task of getting those therapeutics to people around the world who need them, it’s the patients that inspire them.
The company’s complex work is guided by very simple core values: ownership, collaboration, innovation, excellence, and humanity. And the list is punctuated by the directive: Have fun! Unfortunately, their interactions with their large CRO were anything but.
The Quest for a Caring CRO
This company has an experienced internal data management team and understands what excellence looks like. Over time, they began to realize the service they were getting from their CRO did not meet that standard. While the largest CROs often serve the largest pharmaceutical companies in the world, they often overlook their other clients or assign junior team members to oversee their clinical data.
What’s more, while the CRO had powerful tools at its disposal, it couldn’t (or wouldn’t) create the custom reports that were needed.
When the team reached out to PROMETRIKA to discuss the possibility of collaborating on a study, it was clear that our companies have much in common. We are similar in size, have cultures that emphasize mutual respect and support among employees and toward partners, and we share many of the same goals and values.
“Our staff could immediately relate to their team,” says Dr. Miganush Stepanians, President and CEO of PROMETRIKA. “The company’s approach to the work they do, attention to detail, focus on quality, and highly-engaged management mirror the way we do business at PROMETRIKA. We see ourselves as their partner rather than their service provider.”
Taking the Lead on a New Trial
With PROMETRIKA chosen to data manage a new trial, the fact that our companies were well-aligned was immediately apparent in their approach — one that balanced the use of advanced technology with the understanding that there are some needs that technology can’t meet. Being in sync was critical on a trial of this size — a Phase III with over 1,000 screened patients, participating at almost 100 sites nationwide.
Our team designed and built the database, incorporating input from all stakeholders. We also developed specialized programming output for safety reports that provided weekly and bi-weekly metric updates for each site. This allowed the sponsor to be very involved and take action quickly for sites that needed attention. The complex nature of the study also required strong project and data managers and a great deal of flexibility to allow the sponsor teams to have a constant oversight of the data, both of which we were able to provide.
An STDM conversion was required to prepare the data for submission. Our biostatistics experts collaborated with the sponsor team early in the study and provided insight on what the data should look like. This proactive approach helped ensure that data capture and preparation was efficient and effective and ultimately made the trial a great success!