Case Studies
Academic Institutions
Clinical Research Compliance Remediation
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.
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Regulatory filing services, medical writing and study monitoring
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.
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Pharmaceutical Companies
Regulatory Guidance and IND Filing
A clinical stage biopharmaceutical company was ready to take its first complex molecule targeting a rare disease to clinic at the same moment the firm lost its regulatory lead. The client turned to Pearl Pathways for expert regulatory assistance to prepare and file the IND, and guide the firm through FDA’s IND review process.
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Regulatory, Quality Compliance, and CMC Analytical Services
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.
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IRB Review for Multicenter Study
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.
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Clinical Research & Quality Compliance
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.
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Regulatory filing services, medical writing and study monitoring
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.
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Regulatory filing services, medical writing and study monitoring
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.
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Regulatory Strategy Consulting
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.
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Medical Device Companies
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.
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Regulatory Consulting & Clinical Study Support
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.
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Clinical Trial Protocol Writing & IRB Review
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.
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Regulatory filing services, medical writing and study monitoring
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.
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Diagnostic Device Companies
Regulatory & Quality Compliance Consulting Services
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.
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Regional Hospital Research Institute
On demand Clinical Research Coordinator Staffing
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.
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Hospital Healthcare System
IRB Software System QC Services
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.
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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.
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