The Austen BioInnovation Institute in Akron’s Center for Clinical Trails and Product Development (CCTPD) offers integrated product development capabilities, including critical, regulatory and clinical services for companies developing and commercializing medical devices, drugs, biologics and combinations products.
The CCTPD experts each have more than 25 years’ experience in the medical device and biopharmaceutical industries leading development programs, including the design of clinical and regulatory strategies. Our team can design and implement a product development program that will allow you to successfully navigate the evolving regulatory and clinical landscape so you can reach the marketplace sooner. One in the market, we can help you stay there as well.
Our Core Services Include:
Product development/Clinical Research
- Designing integrated, comprehensive product development strategies and project management
- Establishing clinical development programs including protocol design
- Defining optimal clinical utility for your product and your business
Clinical Trials – Attraction and Placement
- Placing clinical trials and trail oversight
- Protocol and clinical trial management
- Providing clinical/regulatory operations support
Regulatory Assessment, Analysis and Strategy
- Due diligence
- Regulatory strategy and pathway
- Marketing Authorization Applications (MAAs)
- Interfacing with regulatory authorities
Regulatory Compliance/Quality Systems
- Compliance and risk mitigations
- Remediation strategies
- For more information on CCTPD, please click on the link below to our full brochure.
To learn more about the Center for Clinical Trials and Product Development (CCTPD), browse and download the resources below:
- CCTPD Informational Brochure (PDF)