Case Studies

Case Studies

Development + Periodontal Disease

The Opportunity

A virtual company identified a novel device for the treatment of periodontal disease. The device required regulatory support and clinical development to maximize its competitive value and ensure its approval by health authorities. The company needed seasoned clinical professionals to initiate its first-in-human studies.

The InClinica Difference

InClinica’s extensive network of key opinion leaders and performance-driven clinical sites accelerated the development of the device to the virtual company’s great satisfaction. Since the device would change the way periodontal disease is treated, InClinica was critical to the success of the project, choosing sites with clinical investigators who had experience with novel dental therapies.

The Outcome

Because InClinica chose the best-performing sites, the company’s enrollment goals were met, and its regulatory package is on its way to a timely submission to its target health authorities.

Development + Dermatology

The Opportunity

A small biotech company identified a novel delivery system for use in non-melanoma skin cancer. The program needed regulatory/clinical support in the drafting of a clinical protocol and investigator brochure, in addition to the management of its first-in-human clinical study. The site selected had to have not only sufficient numbers of the target patient population but also experienced pathology laboratories to measure endpoints.

The InClinica Difference

InClinica’s deep experience in dermatology allowed us to identify a university site capable of meeting enrollment targets and providing the necessary specialized laboratory support. The university investigator and InClinica developed a strong working relationship and maintained excellent lines of communication throughout the study, ensuring the biotech company was well informed of enrollment and other site-related concerns.

The Outcome

Because of the strong relationship forged by InClinica with the site, the biotech company is happy with the progress of the study and meeting its development goals.

Expertise + Oncology

The Opportunity

A young biotech firm had completed a Phase I trial, in which promising results for its oncology drug were being seen in a number of different tumor types. The company knew it was at a critical juncture, but was uncertain which direction it should pursue next.

The InClinica Difference

One of InClinica’s physicians had deep experience in developing oncology drugs, gained both as a sponsor and as a CRO. He modified both the protocol and the development plan to better match the market conditions for evolving oncology therapy. In particular, he recommended a different indication – that the biotech firm focus on pancreatic cancer, which would offer it an easier-to-recruit base of patients.

The Outcome

Because InClinica met its patient recruitment and enrollment goals, the biotech firm was able to reach Phase II proof of concept faster. It was approached by a global pharmaceutical firm with which it entered into a partnership.

Execution + Metabolic Diseases

The Opportunity

A small, private pharmaceutical company with a novel delivery method for an approved diabetes drug approached us. It was anxious to get patients enrolled so that it could get approval for its drug device combination. But the company was unsure about the best clinical sites to perform the study and needed to minimize costs.

The InClinica Difference

With its global footprint, InClinica was able to recommend alternative regions and sites around the world, with fewer competing trials, the ability to enroll patients faster, and options that were within budget.

The Outcome

After we identified the optimal sites for this company and its diabetes compound, the company successfully completed its trial, becoming part of the company’s global submission to regulatory authorities. The sponsor is optimistic that the package will be approved for marketing.

Experience + Inflammation

The Opportunity

Just as a biotech firm was about to receive approval for its analgesic therapy, it received pushback from regulatory authorities, seeking more detailed plans for specific subpopulations of patients—on a challenging deadline. The small company hadn’t previously encountered this type of request from a regulatory body and needed to identify clinicians and other experts to prepare the response.

The InClinica Difference

Within 24 hours, InClinica had connected the biotech firm with two of the nation’s leading experts in analgesia and pain syndromes. Together, they crafted a plan that met the stated regulatory requirements while identifying various conditions suitable for inclusion in the plan.

The Outcome

The regulatory body reviewed the plan and accepted its study outlines.