Clinical and Regulatory Services
We use a specialized, strategic approach that employs a team to do the heavy lifting for a company or provider, helping them confidently and efficiently interact with regulators, improve their regulatory preparedness, and pursue the most appropriate pathways to approval, including FDA’s RMAT designation developed exclusively for regenerative medicine and gene therapies.
Our flexible, turnkey approach to partnering with clients, identifies their needs and fills the gaps often experienced by emerging biotech companies.
Our service competencies to bring your innovations to market are:
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Dedicated Team Assignment (Lead Scientist, Clinical Coordinator, Project Manager, and Administrative Support)
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Strategic Indication Research
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Gap Analysis and Drug Eligibility Assessment(s)
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Pre-Clinical and Clinical Studies and Data Quality Assessment
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Real World Evidence (RWE) and Real World Data (RWD) Evaluation
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510(k) Predicate Use Cellular Action Evaluation
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Customized Regulatory Roadmaps
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Resource Referral
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Translation, Experiment Design, Product Characterization, and Other Services
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Clinical Research Organization (CRO)
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Contract Manufacturing Organization (CMO)
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Business and Strategic Partnerships
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Drug Development
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Chemistry, Manufacturing, Controls (CMC)
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Mechanism of Action (MOA)
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Study Design
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Animal Toxicology
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Institutional Review Board (IRB) Matching
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Investigational New Drug (IND) Planning, Assembly and Submission
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Protocol Development
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Inclusion / Exclusion Criteria
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Synopsis Development
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Precision Informed Consent Form (ICF)
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Investigator Brochure (IB) Development
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Regulatory Meetings and Clinical Response Team Preparation
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Electronic Common Technical Document (eCTD) Submissions
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pre-IND
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IND and Amendments
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Drug Master File (DMF)
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Pre-FDA / Post-FDA Support
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FDA / Other Regulatory Meetings
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INTERACT, pIND, IND
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BLA, NDA
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Clinical Trial Management / Support
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Submissions (CSR, Regulatory, Annual Reporting)
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Clinical Trial Monitoring / Support
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Database Development / Support
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Site / Sponsor Training (ICH, GCP, Protocol)
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Audits (Site, Sponsor, FDA, Compliance)
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RMAT Designation Application and Submission
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Biologics License Application Fee Waiver Submission
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NEW!! *International Technology Transfer Consultation
Strategic Indication Research
Regenerative Outcomes' indication research is a strategically focused approach to selecting a best-case indication that aligns with your operational capacities, resources, and business model, and then recommending or confirming possible target indications a sponsor may consider in order to gain approval for an Investigational New Drug (IND) application, and ultimately qualify for an accelerated pathway to market.
Extensive literature and clinical research review, evaluation of current trials conducted worldwide, compilation of available real-world evidence, and pre-clinical study meta analysis, are just a few resource types applied to our Strategic Indication Research.
cGMP & cGTP
Current Good Manufacturing Practice (cGMP) and Current Good Tissue Practice (cGTP) are detailed standards required for processing research and commercial grade biologic products that are safe for use in humans.
Regenerative Outcomes provides support and direct consultation from seasoned subject matter experts to guide a potential sponsor through this important process.
Precision Informed Consent
As a leader in introducing the need and calling for a national initiative to personalize and modernize informed consent practices within the field of regenerative medicine, Regenerative Outcomes utilizes a principle of "Precision Informed Consent" in the context of Informed Consent Form (ICF) development.
When appropriate, sponsors have the option of including relevant patient outcomes data derived from current publications, clinical studies, medical records, or outside registries to supplement the consenting process for clinical study participants.
Using this approach improves transparency, trust, and understanding of the study subject or their caregiver, and positions the participant for maximum retention in the study.
IRB Matching
An Institutional Review Board (IRB) is a committee of academics and practitioners with the legal obligation and authority to oversee all applicable U.S. medical research on human subjects. Tasked with assessing safety, risk, and providing ethical oversight that protects the human patient, IRB committees collaborate closely with study investigators, and are empowered to approve or disapprove protocols and processes within the research project.
As part of its regulatory services offerings, Regenerative Outcomes helps find well-respected IRB committees that provide a good match for specific in-human research and clinical studies.
Phase I/II Clinical Trial Design
Emerging biotechnology companies and physician groups often have unique support needs that require creative approaches to clinical trial design that will result in as robust and cost-efficient study as possible.
Regenerative Outcomes specializes in helping clinical study groups design studies that are nimble, iterative, and flexible.
R.M.A.T. Designation
The Regenerative Medicine Advanced Therapy (“RMAT”) designation was established by the 21st Century Cures Act. As described in Section 3033 of the 21st Century Cures Act.
Under the Act, a drug is eligible for the RMAT accelerated pathway if:
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The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;
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The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
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Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition