Investigator strategy
Aligning experienced scientific leaders to the indication and protocol.
For sponsors
Investigator-led, multi-site research
We help sponsors pursue rigorous multi-site studies designed to evaluate safety and efficacy, supported by fit-for-purpose, risk-based quality management. We guarantee no approvals, enrollment speed, efficacy, or study outcomes.
What we offer
Network and study coordination for sponsors
Scientific collaboration
Input on study questions, design, and interpretation from qualified investigators.
Research opportunity assessments
Evidence-based assessments of research questions and unmet needs.
Multi-site feasibility
Indication-specific feasibility across candidate sites and populations.
Site qualification and activation
Coordinating qualification, contracts, and activation of independent sites.
Enrollment planning
Planning through IRB-approved methods only, with enrollment tracked against plan.
Study management
Coordinated management of CMBH-managed activities across sites.
Clear reporting
Transparent status reporting for the sponsor throughout the study.
Technical functions such as protocol design, biostatistics, regulatory support, and data operations are performed by SerenaGroup or another qualified partner as specifically contracted.
Two ways to engage
Sponsor-originated or CMBH-originated
Sponsor-originated programs
You bring the program. We help with scientific leadership, qualified sites through Unity Site Network and other investigators, and coordinated execution.
CMBH-originated opportunity assessments
CMBH proposes research opportunities informed by scientific evidence, population needs, and investigator input, for sponsor review.
Roles
Who is responsible for what
Responsibilities are allocated by written contract and delegation. No party is presented as solely responsible for compliance.
| Sponsor | Owns the study and its oversight. Contracts with CMBH and the technical partner as agreed, and keeps its own legal and regulatory duties. |
|---|---|
| CMBH | Scientific leadership, sponsor development, research strategy, L1 investigator relationships, and research opportunities. |
| Unity Site Network | Site development, qualification, activation support, and coordinated site management, primarily L2 and L3, as contracted. |
| Lead scientific investigator | Scientific leadership and advice across sites. Does not automatically replace any site PI's responsibilities. |
| Site PI | Responsible for the conduct of the study at that site, protection of participants, and the site's regulatory obligations. |
| SerenaGroup (independent partner) | Technical and methodological CRO services as specifically contracted, such as protocol design, statistics, regulatory support, and data operations. Services and scope are set in each agreement. SerenaGroup is not a CMBH subsidiary and does not guarantee compliance for any party. |
Tailored research collaborations
Research opportunities shaped around your scientific priorities
Every development program has distinct scientific questions, patient populations and operational requirements. CMBH works with prospective sponsors to explore investigator-led study concepts, evaluate potential site participation, and identify the specialized collaborators each program needs.
- 01
Understand the objective
Start with your indication, evidence gaps and development priorities, not a generic list of sites.
- 02
Explore investigator and site fit
Identify relevant scientific leadership and evaluate candidate practices, geography and feasibility, subject to qualification.
- 03
Develop a tailored concept
A focused, preliminary opportunity brief covering rationale, a possible operating model and questions for diligence.
- 04
Build the right collaboration
Bring in appropriate CROs, academic institutions and technical providers, with responsibilities set in study-specific agreements.
For a confidential, program-specific discussion, contact our team. Please do not submit unpublished protocols, patient information or other confidential material through the general inquiry form. Proposals are prepared independently by CMBH and do not imply any sponsor affiliation or endorsement.
Sponsor-aligned research development
Extend later-stage research through established investigators and qualified sites
Our strategy emphasizes established therapeutic categories, later-stage and post-market evidence needs, and sponsor-relevant research questions. We help sponsors evaluate scientific leadership, protocol-specific site readiness and potentially eligible patient populations, without promising enrollment or assuming a study award.
Aesthetics and neuromodulators
Feasibility involving established treatments, patient selection, outcomes, repeat treatment and longer-term evidence needs.
Migraine and neurology
Later-stage and real-world evidence opportunities involving consistent assessments and longitudinal outcomes.
Behavioral health and neurodevelopmental
Open to devices, digital therapeutics, behavioral interventions, observational studies, pharmaceuticals and other scientifically justified approaches. Regulatory pathways are product-specific.