Case Studies

Here are some real life examples of how Pearl’s breadth of services has created solutions for companies  ranging from  startups to multi-national drug and device companies and regional research hospitals.

Academic Institution: A large academic hospital institution approached Pearl to assist with remediation of an oncology clinical research department. The hospital’s clinical trial enrollment had been suspended for a number of studies due to lack of GCP compliance. To see how Pearl helped, click here.

Pharmaceutical Company: A small pharmaceutical company was preparing for a 505(b)(2) submission for a drug with a novel delivery device.  The client approached Pearl Pathways to provide general quality compliance services, pivotal clinical trial support, as well as regulatory strategy and filing support.  To see how Pearl helped, click here.

Pharmaceutical Company:  A small-tier pharmaceutical company and their CRO approached Pearl IRB with an urgent need for an IRB review for a multi-site phase III registration study for their oncology drug.  To see how Pearl helped, click here.

Pharmaceutical Company: A founder of a small oncology company approached Pearl with a need for Investigatory New Drug (IND) filing support.  The ultimate scope of services included oversight of the manufacturing of the clinical research materials, vendor assessments, quality system creation, authorizing the IND and leading FDA interactions for a pre-IND meeting.  To see how Pearl helped, click here.

Pharmaceutical Company: A global top five pharmaceutical company sought the services of Pearl Pathways for CMC regulatory support. The pharmaceutical company had recently reduced its workforce in anticipation or some organization changes which did not occur.  A senior leader at the pharmaceutical company reached out to Pearl to fill this gap in regulatory support. To see how Pearl helped, click here.

Pharmaceutical Company: A small therapeutics firm with a limited quality assurance staff sought out Pearl Pathways to help them with pre-approval inspection (PAI) of their facility. The company had recently submitted a new drug application (NDA) and they knew they needed to help prepare their contract manufacturer (CMO) for the upcoming FDA inspection. To see how Pearl helped, click here.

Medical Device Company: A large medical device company asked Pearl IRB to assist them with a post marketing surveillance study for an implantable device.  The scope of the study was to follow patients post surgery for ten years tracking outcomes and safety.  To see how Pearl helped, click here.

Medical Device Company: Prior to engaging Pearl Pathways, a small startup medical device company filed a 510k for their imaging device.  During 510k negotiations, FDA requested additional data and for the company to design and execute a clinical study.  To see how Pearl helped,  click here.

Medical Device Company: A small medical startup device company submitted a 510k for a class II diagnostic device with strong established predicates.  The existing five predicates were not required by the FDA to do clinical research studies in order to gain market clearance, but the FDA required this startup to execute a clinical trial.  To see how Pearl helped, click here.

Medical Device Company: A large orthopedic medical device company approached Pearl Pathways for medical writing services for the creation of several clinical evaluation reports (CER) for upcoming CE Marking regulatory submissions for implantable orthopedic medical devices. The scope included new and existing medical devices. To see how Pearl helped, click here.

Diagnostic Device Company: A large genetic testing company approached Pearl Pathways with several regulatory and quality compliance needs.  The client was expanding their products to include CDRH regulated diagnostic devices.  To see how Pearl helped, click here.

Academic Institution: One of the country’s largest academic research institutions reached out to Pearl Pathways asking for assistance with a clinical study and regulatory filing for a cardiac medical device.  To see how Pearl helped, click here.

Regional Hospital Research Institute: The staff at a regional hospital research institute asked Pearl to assist them with filling gaps they had with sufficient Clinical Research Coordinator (CRC) support.  Their oncology division had been trying to fill two CRC positions for several months and needed immediate research support in order to implement their existing protocols.  To see how Pearl helped, click here.

Hospital Healthcare System: A large hospital healthcare system was transferring IRB files from a legacy software system to a new cloud-based system. The IRB leader approached Pearl Pathways to provide quality compliance services (QC) for the transfer. To see how Pearl helped, click here.

Pharmaceutical Company: A mid-tier pharmaceutical company approached Pearl for help in preparing an IND for a biologic product and providing consultation on phase 4 post approval supplements. To see how Pearl helped, click here.

Biopharma Startup client: A startup biopharmaceutical company asked Pearl for assistance with medical writing to prepare for needed publications in support of an upcoming IND approval and launch. The client required assistance composing several pharmacokinetics publications, abstracts and posters. To see how Pearl helped, click here.