Clinical Operations expertise, how and when you need it.
Flexible, senior-level Clinical Operations leadership and delivery support for emerging biotechs, clinical-stage companies, specialist CROs and teams navigating periods of intense operational demand.
Flexible senior support across the study lifecycle.
Different organisations reach the same pressure point for different reasons: a study is starting, delivery has become more complex, outsourced activity needs stronger oversight, or senior capacity is temporarily stretched.
CPM can step in at those points with focused Clinical Operations leadership that complements the team and operating model already in place.
Emerging and scaling biotechs
Senior operational leadership before, during or alongside the build-out of permanent Clinical Operations capability.
Clinical-stage sponsors
Additional oversight and operational control across CROs, vendors, sites, timelines, risks and critical study decisions.
Teams at a critical transition
Experienced capacity around start-up, programme expansion, leadership gaps, inspection readiness or pivotal planning.
Specialist CROs and technology providers
Senior Clinical Operations expertise supporting client delivery, operating models, independent review or human validation of technology-enabled workflows.
Where we can add value.
Practical support from clinical planning and study start-up through outsourced delivery, sponsor oversight and inspection readiness.
Fractional Clinical Operations Leadership
Senior, hands-on operational leadership on a flexible basis.
- Study/team leadership
- Cross-functional coordination
- Risk, timeline & budget oversight
Study Start-up & Delivery
Translate clinical strategy into an executable operating plan.
- Feasibility & site selection
- Regulatory workflow coordination
- Patient pathway & logistics
CRO & Vendor Oversight
Experienced oversight of outsourced delivery and vendor performance.
- Vendor evaluation
- Governance & KPIs
- Issue escalation
TMF & Inspection Readiness
Move beyond document collection towards evidence of study control.
- TMF oversight
- Cross-functional reconciliation
- Readiness review
Operational Planning & Risk Management
Structure timelines, responsibilities, risks and decisions around the realities of execution.
- Operational plans
- Risk/action tracking
- Governance support
Project & Programme Support
Additional senior capacity around defined workstreams, transitions or workload peaks.
- Project-specific delivery
- Recruitment-gap coverage
- Defined reviews
Flexible by need, not by a fixed delivery model.
Real-world challenges. Practical solutions.
Experience snapshots showing the kinds of operational challenges CPM can help address.
Senior judgement with hands-on delivery.
CPM is built around experienced Clinical Operations input, flexible capacity and the realities of sponsor accountability in outsourced development models.
Independent judgement without creating another unnecessary layer.
CPM can work directly with sponsors to strengthen oversight and operational control, or support specialist CROs and technology providers where senior Clinical Operations input is needed. The common thread is experienced operational judgement that works with the existing delivery model rather than automatically replacing it.
The right level of visibility for each decision-maker.
CPM can help build oversight processes and dashboard-style reporting that turn study milestones, risks, actions, site and vendor performance, and documentation status into useful views for different audiences.
Study teams can work from detailed operational information, while programme leads and senior stakeholders receive progressively more focused summaries for decisions and escalation.
Technology-enabled oversight with human validation.
Where appropriate, technology-assisted workflows can help structure and reconcile study information, run targeted comparisons, surface exceptions and turn fragmented inputs into more focused oversight outputs. The aim is not to replace Clinical Operations judgement, but to help experienced reviewers concentrate attention where it is most useful.
Experienced Clinical Operations or other relevant domain professionals validate context, assess significance and finalise any client-facing finding or report.
Sarfraz Nawaz
B. Pharm, MBAMore than 20 years of clinical research and Clinical Operations experience across CRO, pharmaceutical and biotechnology environments, spanning early-to-late phase development, observational programmes and global studies.
Experience includes sponsor oversight, CRO and vendor management, site feasibility, study start-up and delivery, governance, inspection readiness and advanced therapy programmes. UK-based, CPM supports programmes across the UK, Europe and global sponsor models.
Clinical Operations support is grounded in ICH-GCP principles, sponsor oversight responsibilities and inspection-ready ways of working.
View LinkedIn profileWhat you may want to know before working with CPM.
From engagement models and CRO collaboration to study stages, global support and technology-enabled services.
View all FAQs →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.
When Clinical Operations gets complex, a clear next step matters.
Whether the pressure is study start-up, outsourced delivery, sponsor oversight or temporary capacity, CPM can help define the issue and work towards a practical way forward.
