Scientific Excellence & Partners

Leading Investigators. Established CRO Expertise.

CMBH builds the investigator and site network. SerenaGroup contributes established clinical research methodology and technical expertise. Together the model combines investigator credibility, patient access, and research execution expertise.

Two parts, one model

CMBH and SerenaGroup

CMBH with Unity Site Network

Investigators, sites and coordination

CMBH brings the investigators, sponsor relationships and research opportunities. Unity Site Network develops and coordinates participating research sites.

Sponsor relationship and research strategy
Investigator matching
Site development and feasibility
Reporting, as contracted

Technical CRO partner

SerenaGroup

An independent strategic partner. Brings established clinical trial methodology and capabilities that may include protocol design, regulatory support, data management, biostatistics, clinical operations and quality systems, according to the scope of each engagement. Its wound-care background can support Unity and CMBH programs.

Services as specifically contracted
Scope set in each agreement
Sponsors and investigators keep their own duties

SerenaGroup services are provided only as contracted for each study. SerenaGroup is an independent company, not owned by CMBH. CMBH does not present itself as a full-service CRO.

SerenaGroup-reported experience

In SerenaGroup's own numbers

25years of clinical trial experience

200clinical trials

283research sites in the SerenaGroup network

2,500lectures, and 400 articles

These figures are SerenaGroup-reported, as published at serenagroups.com, and are not CMBH accomplishments. SerenaGroup's experience is substantial in wound care and tissue repair. CMBH is not limited to wound care and will recruit indication-specific scientific leadership for other therapeutic areas. This does not mean SerenaGroup has run studies in every CMBH therapeutic area.

Scientific Excellence & Academic Collaboration

Rigor first

We plan to work with qualified academic researchers, scientific advisors, and institutions on research questions, study design, independent scientific input, and responsible publication.

We seek to combine the scientific rigor of academic research with the reach and efficiency of a coordinated national physician network.

Scientific rigorData integrityReproducibilityRisk-based quality managementTransparent reportingClinically meaningful evidenceRegulatory readiness

Scientific Advisory Council Proposed

A council of investigators and scientific advisors is proposed. It does not exist until members formally agree. Names, affiliations, and credentials will be published only with permission, and no academic institution endorses or partners with CMBH unless a written agreement says so.

Responsible data sharing

Sharing and peer review follow sponsor agreements, participant consent, privacy, confidentiality, publication rights, and applicable law. We support responsible dissemination and peer-reviewed publication where appropriate. Raw patient data is not universally available.

Good studies test safety and efficacy. They do not guarantee positive outcomes.