Clear answers about how CPM can work with your team.
Questions about fractional support, sponsor oversight, CRO relationships, engagement models and where CPM fits in the clinical development lifecycle.
Fractional Clinical Operations leadership gives a sponsor access to experienced, senior operational support for an agreed portion of time rather than through a permanent full-time hire. CPM can provide hands-on study leadership, governance, cross-functional coordination and sponsor-side oversight according to the needs of the programme.
Support can be valuable before a company builds permanent Clinical Operations headcount, during study start-up, when workload or complexity increases, during a recruitment gap, or where an outsourced study needs stronger sponsor-side coordination and oversight.
CPM is not intended to replace a CRO. A CRO may execute substantial parts of a clinical trial; CPM can sit on the sponsor side to help plan, coordinate, oversee and connect those activities so the sponsor retains appropriate visibility and control.
Yes. Much of the value is in working alongside existing CROs, specialist vendors, sites and internal functions: clarifying responsibilities, coordinating dependencies, reviewing delivery and escalating issues where sponsor attention is needed.
No. CPM is a Clinical Operations consultancy and partner. Engagements are based around defined operational support, leadership or deliverables. Where a programme requires expertise outside CPM’s core Clinical Operations capability, additional specialist support may be brought in by agreement.
CPM is UK-based, with particular familiarity with UK and European clinical development environments and experience supporting multinational/global programmes. The intended service model is not limited to UK clients.
Engagements can be structured around regular fractional support, a defined project or workstream, support across a specific study or development stage, or an independent review such as vendor/TMF/readiness assessment. The exact model should reflect the operational need rather than force a fixed package.
Yes. A key use case is helping an early biotech translate development plans into an operationally executable clinical study before permanent Clinical Operations headcount is justified. This can include operating model development, feasibility, vendor evaluation, start-up planning and study-document coordination.
Experience spans early-to-late phase clinical development, including first-in-human/early-phase work, observational programmes and global late-phase studies. Advanced therapy experience includes cell and gene therapy programmes.
Relevant experience includes oncology, ophthalmology, hepatology, respiratory/pulmonary vascular disease, neurology and IBD, with advanced therapy experience across gene therapy and autologous cell therapy.
CPM is exploring and developing technology-enabled oversight approaches for selected workflows. Where an appropriate capability is available, technology may be used to structure or accelerate review, with findings intended to be human-validated before client use. Exact tools and availability are agreed for the specific engagement.
Yes. An initial conversation can remain high level. Where confidential programme details need to be shared, the parties can agree an appropriate confidentiality agreement before substantive information is exchanged.