Award Winning Uk Full Service Cro

Extend your capabilities. Expand your reach.

Give your sponsors access to UK and European clinical trial expertise through one trusted CRO partnership.

Talk to us about partnering

A unified solution for your sponsors

Complementary capabilities

Extend your existing offering with the UK and European expertise, services and resources your sponsor needs.

Seamless delivery

We work as an extension of your team, with clear responsibilities, joined-up communication and shared accountability.

A partner you can trust

Your sponsor relationship matters to us. We work collaboratively behind the scenes, representing your organisation and ours with the same care.

Extend your clinical trial capabilities

Add the expertise you need without having to build additional infrastructure or resource in-house.

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Clinical Trial Development

Study/Project Management

Monitoring
Clinical writing icon

Clinical Writing
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Regulatory Affairs

Safety Management

Data Management

Biostatistics

Quality and Compliance
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Clinical Writing

Includes development of clinical study protocols, patient facing documents (including patient information sheets, informed consent forms) and clinical study reports to ICH E3 or ISO standards.

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Regulatory Affairs

Includes the preparation and management of clinical trial applications, substantial amendments and end of trial notifications to the Competent Authorities.

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Safety Management

We work with you to support the safety management aspects for your trial from assisting with developing the safety sections of your protocol/clinical investigation plan, through to processing of serious adverse events/serious adverse device events (SAEs/SADEs) and expedited reporting of unexpected serious adverse drug/device reactions (SUSARs/USADEs) to the regulatory authorities, ethics committees and investigators. We also have the capabilities to develop robust and applicable safety monitoring plans and manage the set up (and attendance if required), of independent drug safety monitoring committees (IDMCs).

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Data Management

We work with highly experienced partners who provide a single platform solution for electronic data capture. The electronic data capture software is fully 21 CFR Part 11 compliant. Full control is provided to assign which users can access, sign and modify forms. It also supports visit scheduling, real-time edit checks,  automated initiation and resolution of queries, real time data listings, and integrates with GlobalTrace EDC to provide kit tracking if required.

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Biostatistics

Our experienced biostatistical partners will work with you proposing statistical approaches, innovative study designs and analytical methodologies and build them into your statistical analysis plan (SAP). Our Biostatistics team can create randomisation schedules, submission ready datasets, TLF generation and reporting, data safety monitoring board (DSMB) outputs and can support interim analysis, exploratory analyses and support for manuscripts and abstracts.

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Quality and Compliance

We will ensure a Quality Management Plan (QMP) is produced for your study so you can be assured it is conducted to the highest standards. We can provide CQA services to help our clients and sites develop the most effective methods for correcting and preventing any non-conformities. Among the CQA audits we conduct are: Clinical investigator site audits (routine, directed and pre-inspection audits to help sites prepare for regulatory inspections), clinical study document reviews (Trial Master File and Site File), system audits (in which we assess a client’s standard operating procedures (SOPs) and processes and recommend improvements where needed) and vendor audits (in which auditors evaluate a client’s vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations). Finally, we can be there to help you through Regulatory Inspections, from preparation and supporting through to the inspection days and assistance in forming responses and Corrective and Preventative Actions plans (CAPAs).

Looking for a UK CRO partner?

Talk to us about your requirements

Different CROs. One joined-up team.

Sponsors don’t want to spend their time working out which CRO has oversight of what.

We establish clear roles and responsibilities from the outset and work closely across both organisations to create a coordinated approach to delivery.

For your sponsor, it feels like one team.

  • Clear ownership and accountability
  • Joined-up communication
  • Consistent ways of working
  • No unnecessary duplication
  • Issues addressed together
  •  A seamless sponsor experience

A partnership that works around you

Our CRO partnerships aren’t one-size-fits-all.

  • Need a UK CRO partner for a single study? We can support you.
  • Need to fill a specialist capability gap? We’ll complement your existing team.
  • Need a long-term UK and European delivery partner? We can build a model that works across opportunities.
  • You bring your strengths. We bring ours. Together, we give the sponsor what they need.

What our CRO partners say

"What really stands out about PHARMExcel is their flexibility and the way they approach each trial. Their team is responsive, collaborative and always willing to go the extra mile. We trust them to work alongside our teams and represent us well with our sponsors."

Head of Clinical Operations, CRO Partner

You and your sponsors are in good hands

  • Flexible & responsive
    We adapt to your study, your team and your way of working.
  • Collaborative
    We work as an extension of your team, not another layer for you to manage.
  • Clear & transparent
    Roles, responsibilities and communication are agreed from the outset.
  • Experienced
    Senior clinical trial expertise across complex UK and European studies.
  • Sponsor-focused
    We protect the relationship you’ve built and focus on delivering a great experience for your sponsor.

Our certifications and affiliations

SEHTA award logo

Book a call to see how we can support your study

Let’s deliver more for your sponsors. Talk to us about partnership opportunities

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