Remember those TV commercials that featured a product and touted its wonderful properties, only to continue with, “But wait! There’s more!”? Sometimes, I feel like that about the services that Pearl Pathways offers. Pearl Pathways is all about accelerating product development—we help our clients get their products to patients faster. When people encounter Pearl, they may think of the regulatory assistance that we provide, but there is so much more to us than providing regulatory strategy and helping to draft and submit INDs, IDEs, NDAs, BLAs, 510(k)s, PMAs, etc. to FDA or CTAs and MAAs to regulators outside the United States.
Quality Assurance and Quality Compliance Services
But wait, there’s more! Did you know that we can help you set up a Quality system? This can be critically important for small, virtual companies who may not have the resources to do this in-house. We can provide everything from authoring a Quality Manual or Standard Operating Procedures, to auditing potential suppliers and training staff.
Accredited IRB for Human Subjects Research
But wait, there’s more! Did you know that we have an independent Institutional Review Board (IRB)? Our IRB is fully accredited by the Association for the Accreditation of Human Research Protection Program Inc. (AAHRPP). Our team is comprised of experts in the fields of medical practice, science, ethics and clinical research. We ensure that the proposed study is completed to assure regulatory and quality compliance so that patient, sponsor, and research goals are achieved. Whether you are seeking a quick turnaround on a small single-site study or require a single IRB of record for a large, multi-site clinical trial, Pearl IRB is fully capable of supporting a wide variety of research spanning all types of research, products, and indications.
Full-Service CRO for US-Based Clinical Trials
But wait, there’s more! We have a full-service, niche CRO. Our medical and clinical research experts provide clinical operations support, clinical site qualification and monitoring, GCP auditing, CMO, bioanalytical, and pharmacovigilance services. We also provide medical writing support for protocols, informed consents, IBs, CERs, clinical development, monitoring, TMF plans, clinical SOPS, and regulatory submissions. Our staff delivers comprehensive solutions to assist in the planning and execution of clinical research for institutions, sponsors, CROs, and more.
Due Diligence for Life Science Industry Investors
But wait, there’s more! We can help with the challenges of due diligence. Whether you are an investor who needs to investigate an asset that you are considering purchasing or you are a firm with an asset that an investor is interested in acquiring; we can provide an evaluation that will identify the challenges to developing the asset further and outline potential paths forward with solid estimates of time and costs involved, based on the decades of experience our staff has in the pharma industry and with FDA and other regulatory authorities.
In all seriousness, it is Pearl Pathways’ mission to ensure that our clients successfully navigate the highly regulated life science environment by balancing risk, speed to market, and cost to achieve their business goals. Contact us today if you are vetting new partners to support your product’s development pathway. Our “operators” are standing by.