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Pleiad Knows Your Business

Pleiad is different from “combination” CROs who do both pharma and device work. We specialize in clinical research for medical device companies. We understand the regulatory issues and are well versed in all aspects of clinical trials for both marketing and regulatory submissions.

Pleiad’s clinical research team has years of experience in designing, organizing and managing clinical projects for medical device companies. We ensure compliance with all relevant FDA and EU clinical research regulations so that all clinical data meet the regulatory standards of the major medical device markets. For marketing trials, we ensure that the data generated are of high quality to ensure acceptance by the selected scientific journals.

The optimal way to ensure compliance is to have experienced clinical research personnel design, organize and manage your clinical investigation or trial. If you lack such individuals in-house, outsourcing this work makes sense. Many contract research organizations specialize in clinical trials for pharmaceutical companies, however their inexperience with medical devices is reflected in their price structure, approach and the teams they provide.

We provide quality clinical research services. These will serve your regulatory, marketing or reimbursement clinical research needs in both North America and Europe. We also assist with crisis management such as dealing with unexpected adverse non-clinical or clinical data, taking remedial action when a study has gone out of compliance or working with regulators who do not see the full merit of your clinical data package. We are also experienced in dealing with due diligence visits by potential partners and investors.

Our services include:

1. clinical evaluations and literature reviews
2. study design
3. study protocol/clinical investigational plan preparation
4. clinician/surgeon identification
5. site selection
6. management of IRB/Ethics Committee submissions
7. clinical research regulatory submissions
8. regulatory documentation preparation including investigators brochures and instructions for use
9. investigator meetings, DSMBs and advisory boards
10. clinical project management
11. site initiation
12. vigilance and safety monitoring
13. monitoring
14. data management
15. statistical analysis
16. report writing
17. manuscript preparation

Whatever you need to ensure that your clinical research program is compliant, timely and within budget, Pleiad will tailor our offering to you to meet those needs. We work in compliance with our own or our clients’ SOPs.