Opportunity:
Conduct in vivo studies involving submandibular injections of a gel-forming product.
Previous efforts by the incumbent CRO had not met client expectations, specifically related to the quality and reproducibility of the results. The client was also confronted with a broad inability among providers to perform submandibular injections in particular — and customize in vivo activities in general.
Challenges:
Ensure on-site technical expertise to perform submandibular injections that demanded absolute precision; the test material became a gel on contact with water so there were no opportunities for second chances.
Coordinate all logistics of multiple days of injections to align with schedule of client’s out-of-state consultant, who was to be present for procedures.
Coordinate details of formulating the test material, which had to occur on the day of injection — most often within minutes of injection.
Work within limited budget.
Outcome:
Identified and arranged for the services of an experienced surgeon with submandibular gland injection expertise to ensure successful intraglandular injections through the conduct of a cost-effective pilot study.
After successful completion of pilot study and performing submandibular gland injections in the presence of the client’s pre-clinical consultant, ILS was awarded an additional six studies from the client within a year.
Following the initial studies, client named ILS as the sole source for histopathology services for all future studies. ILS generated a scoring system and performed numerous microscopic examinations of samples provided by outside sources. (The quality of the 3rd party tissues was often less than ideal, adding an additional challenge to the process.)
