SerenaGroup helps medical technology companies align Medicare reimbursement, FDA strategy and clinical evidence from the start, before costly decisions are locked into the development program.
A study designed for one audience rarely satisfies the others. FDA, CMS and commercial payers each ask a different question, and the answers are easier to build into a protocol than to add to one later.
Regulatory strategy, clinical evidence and reimbursement are usually planned in sequence. Planning them together is what keeps a development program from paying for the same evidence twice.
of 510(k) submissions receive an FDA Additional Information request during the first substantive review cycle.
does not guarantee Medicare coverage or payment.
CMS treats coding, coverage and payment separately.
is the reported average path to nationwide coding, coverage and payment.
A trial designed only for FDA may not generate the evidence CMS, payers or the market need.
SerenaGroup helps companies align regulatory strategy, reimbursement planning and clinical evidence early, before costly decisions are locked into the development program.
Development programs stall when the protocol, the regulatory plan and the payment plan are designed separately. SerenaGroup brings them together.
Coding, coverage and payment approached as three separate decisions, and considered before the protocol is locked.
A regulatory path defined early, so the evidence you generate is the evidence the submission calls for.
Protocols written with endpoints, inclusion criteria and visit schedules that trial sites can deliver.
Site selection informed by direct experience of which sites see the patients a protocol needs.
Trial conduct by a physician led research organization that specializes in wound care studies.
Analysis planned around the questions regulators, CMS and payers are likely to ask.
Support preparing trial results for peer reviewed publication.
Founder and Chief Executive Officer, SerenaGroup
Dr. Serena founded SerenaGroup, the physician driven research organization that has become a trusted source of evidence in wound healing. He brings experience in wound care innovation, clinical research, product development and regulatory strategy to the sponsors he advises.
Because SerenaGroup also designs and runs clinical trials, his advice comes from teams doing this work.
Build the right evidence once. Build it for approval, reimbursement and adoption.
For medical technology manufacturers, sponsors and innovators. Share a little about your product and what you need.
Please do not send confidential product data or patient information through this form. We will arrange a confidentiality agreement before any detailed discussion.
