Inspire Pharmaceuticals Gains Trial Visibility and Cost Savings with Clinipace Worldwide’s Technology-Amplified Approach to Clinical Trials

Inspire Pharmaceuticals, a North Carolina-based biopharmaceutical company, focused on developing and commercializing prescription products for ophthalmic and pulmonary diseases previously worked directly with investigative sites to manage clinical trials for its initial drug portfolio. Generally reluctant to outsource the management of studies, the company felt it was good at developing relationships with investigators and worked hard to build and maintain those relationships.

However, as their portfolio grew, the company began to realize that time spent managing trials was time taken from development and other core competencies. One of the key executives on the clinical operations team had significant experience working with large CROs, and he knew the particular dynamics of those relationships that worked, and those that didn’t. For example, in the past, even when asking for very basic study metrics, it would sometimes take weeks to get an update. Accordingly, study visibility and open access to real-time data were high on the company’s list of priorities for strategically engaging the right CRO partner.

The company had previously deployed another of Clinipace’s technology-based research software solutions and thus established a good working relationship with the executive team. As a result, they selected Clinipace Worldwide to manage and deploy two Phase II randomized placebo-controlled studies for an ophthalmic prescription medicine.

Process in Motion

For the studies, Clinipace provided technology-driven clinical trial services including data management (EDC), clinical monitoring, site management, regulatory document management, and biostatistical consulting. The project team utilized Clinipace’s TEMPOTM for Clinical Trials software to manage site initiation, patient enrollment and randomization, clinical data capture, and much more. TEMPO’s dashboard shows real-time data such as patient enrollment, reports, and other notifications – greatly increasing visibility into the ongoing trials.

We share a common goal with Clinipace of changing the way we approach the clinical development process – shifting away from some of the more traditional CRO processes and moving towards an integrated technology-driven model.
- Senior Director, Clinical Ops [Inspire]

Conducting the studies electronically provided real-time visibility into site data, compared to a more traditional and time-consuming process of submitting multiple queries and addressing discrepancies towards the end of a study. Clinipace credits a strong relationship with its study sites in generating transparent data throughout the entire research process –valid data was input electronically, monitors did their jobs expertly, and necessary changes were made as required so site visits were more efficient and productive. As a result, teams were able to “clean” data as they went along and ultimately close-out the second longer-term Phase II study 2-weeks earlier than originally planned

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The successful completion of the two Phase II studies set the foundation for a longer-term relationship between Clinipace Worldwide and the pharmaceutical company. Clinipace closed out a data management project for a Phase IV study in early 2010 and a Phase II pediatric study recently went live and enrolled its first patients. Clinipace will support the Phase II trial with data management and biostatistical consulting.

Having the opportunity to strategize and collaborate with a trusted clinical research partner in an ongoing relationship allows you to fine-tune processes and apply best practices for future engagements. We’re always looking at, ‘What can we do better for the next phase or project?’, ‘How are we going to handle this type of situation in a bigger study?’ By building relationships with project managers, we have a head-start for the next phase or project knowing what they’re looking for, how they operate, and how we can help the workflow run more efficiently within their parameters.
- Chris Porter, COO [Clinipace Worldwide]

Measuring Success

Since building a strategic partnership with Clinipace Worldwide, the pharmaceutical company has reaped the benefits:

Greater visibility and two-way communication
Clinipace Worldwide and the company built a successful business relationship based on transparent information exchange, mutual trust, honesty, and open communication. With fewer layers of management to navigate, the company gained greater visibility into all aspects of their trials and better two-way communication with the Clinipace team. The company credits Clinipace’s responsiveness for helping to avoid problems and mitigate risks.

We especially like having the ability to communicate directly with senior members of the Clinipace team. It is important to us that we are important to them. As much as we value open communication, trial visibility is equally important as many program decisions must be made internally.
- Senior Director, Clinical Ops [Sponsor]

Strong working relationships with research sites
As a clinical operations-oriented CRO, Clinipace Worldwide emphasizes the need for building strong working relationships between experienced site monitors and the company. Clinipace’s clinical team serves as technology advocates, acting as an extension of the company’s staff, actively participating in team meetings and mission-critical decisions.

As a relatively small biopharma company with several parallel projects, we see real competitive advantage in building a strategic partnership with a responsive CRO who can maximize the operations of our clinical programs. Every efficiency gain goes right to our bottom line.
- Senior Director, Clinical Ops [Sponsor]

Rapid course corrections
Operating under a fixed-price contract allowed Clinipace to make rapid course corrections based on real-time information. Clinipace has the flexibility and agility to make changes to deliverables and deadlines by mutual agreement among team members, as opposed to extended negotiations, scope of work changes, and contract addendums.

We’re hearing from the market time and time again that companies are tired of having over-scaled and over-priced resources pitched to them. That’s the driving force behind our dedication to providing innovative companies a scalable solution with the right kind and quantity of resources to match any size clinical study and operational approach.
- Chris Porter, COO [Clinipace Worldwide]

Optimally designed trials
Optimally designed trials that are conducted correctly the first time are crucial for success. Clinipace has the breadth of expertise to design trials for the company that helped to achieve stated clinical, regulatory, and commercial objectives in a focused and efficient manner – all within their stringent timelines.

Maximized efficiencies and reduced costs
Rather than depend on volume for efficiency gains, Clinipace Worldwide seeks innovative new technologies and processes that often can’t be introduced into larger CROs with entrenched procedures. For example, Clinipace’s TEMPO technology platform brought together multiple sources of data that would have otherwise needed manual intervention.

Emphasize core strengths
Capitalizing on Clinipace’s expertise and capabilities as a CRO has allowed the company to focus on its own core strengths rather than organize, create, and administer a complete clinical trial themselves.

* Inspire was acquired by Merck in 2010

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