Capabilities - Clinical Device Group Services

Capabilities...
CDG offers a full range of pre-approval services for marketing assessments, biocompatibility expert reports, CRO services, statistics, regulatory submissions, technical writing, registry studies, DSMB board management, and audits. Click on the buttons below to learn more about our capabilities.

Marketing	Our marketing experts can research the field to provide competitive intelligence or best market strategies.

Biocompatibility	Our toxicologists can review your materials to recommend tests or justify their omission.

Sponsor Services	Are you a foreign company needing a US sponsor? We can help.

Protocols & Study Documents	Our clinical professionals can bring a reviewing eye to your protocol or help you set up study documentation.

Sample Sizes	The age-old question: how many subjects do I need? Our statisticians can propose options to reduce your sample size.

Project Management	Need someone to prepare a Gantt chart, estimate a budget, and plan for resources? We can manage your project, too.

Regulatory Services	Our regulatory professionals can help prepare the IDE, and later the 510k or PMA.

Monitoring	Implementation is the hardest part. CDG has regional monitors across the US.

Database Design & Data Entry	Eventually the data must be computerized. We can design the database and input the numbers.

Statistical Analysis	Our expert biostatisticians can analyze the data and prepare the final clinical report.

Reports & Manuscripts	And finally, you'll want to publish. Our technical writers can guide you through the process.

Audits	If you need a check-up along the way, we can audit sites, sponsors, or other centers.
All of which leads to Marketing Approval!

Capabilities...