New research
From development concept to a study ready to start
Preparing a clinical study means aligning scientific objectives, regulatory requirements and operational capabilities. We help biotech companies and sponsors translate their development goals into a practical study plan, with clearly defined responsibilities, realistic timelines and a budget matched to the scope of the project.
Whether you are preparing your first clinical trial or planning the next stage of an established development programme, we tailor our support to your product, available evidence and in-house resources.
Clinical development strategy
We review your development objectives and existing evidence to identify the clinical questions your programme needs to answer. We advise on study objectives, development milestones and the sequence of activities needed to move towards clinical research, including early-phase and bioequivalence studies where relevant.
Study design and documentation
We support the development and review of study concepts, synopses, protocols and participant-facing documents. We help define the study population, endpoints, procedures and visit schedule, balancing scientific value with feasibility, participant burden and the realities of delivery at research sites.
Sponsor readiness
We help sponsors establish the processes and responsibilities needed to prepare and oversee a clinical trial. This includes defining internal roles, identifying gaps in procedures and resources, planning oversight and determining which activities should be managed internally or assigned to external providers.
Site and vendor selection
We support the identification and assessment of research sites, CROs and other service providers. We help prepare feasibility assessments, review proposals and compare capabilities, budgets and delivery assumptions so that partners are selected against the needs of the study.
Regulatory submission planning
We help organise the documentation and activities required for clinical trial applications, including support with CTIS submissions for EU trials. We coordinate contributions from the sponsor and its partners, review documentation for consistency and support the preparation of responses to questions raised during assessment.
Study start-up planning
We bring these elements together into a coordinated start-up plan covering key activities, dependencies, responsibilities, timelines and costs. We help identify potential obstacles early and define the steps needed to prepare the sponsor, study team and selected sites for initiation.
A clear route to study initiation
Our support can cover the full preparation process or a specific task requiring additional expertise. The scope and deliverables are agreed around your project, giving you a clear view of what needs to be done, who will do it and what is required before the study can begin.
Ongoing study
Expert support throughout study delivery
An ongoing clinical study requires coordinated decisions across medical, operational and regulatory activities. We help sponsors and biotech companies maintain oversight, address emerging challenges and keep study activities aligned with the protocol and development objectives.
We can support your existing team, provide expertise for a specific issue or take on agreed responsibilities within the project. Our involvement is tailored to your study’s stage, complexity and current needs.
Sponsor oversight and study coordination
We help sponsors maintain a clear view of study progress, delegated activities and outstanding decisions. We support communication between the sponsor, CRO, research sites and other providers, clarify responsibilities and establish practical reporting and escalation processes.
Site and vendor performance
We review recruitment progress, site readiness, delivery timelines and the performance of contracted providers. When difficulties arise, we help identify their causes and agree practical steps with the teams involved. Our combined sponsor and site experience allows us to assess issues from both perspectives.
Medical monitoring and clinical input
Our physicians provide medical monitoring and clinical advice within an agreed scope. We support the review of eligibility questions, protocol-related medical issues and emerging clinical information, working with investigators and the sponsor’s safety team to facilitate timely, informed decisions.
Protocol amendments and study documentation
As a study progresses, new information or operational experience may require changes. We help assess the implications of proposed amendments, update study documents and coordinate their implementation. We also support relevant CTIS activities and responses to regulatory questions.
Operational problem-solving
We provide focused support when recruitment slows, responsibilities become unclear or delivery falls behind plan. We work with the study team to assess the situation, prioritise actions and develop a realistic recovery plan, taking account of participant safety, data reliability and available resources.
Study completion and reporting
We support planning for study completion, coordination of outstanding site and vendor activities, and preparation or review of clinical study reports and related documentation. We help teams organise the information needed to interpret study outcomes and inform subsequent development decisions.
The expertise you need, when you need it
Our support can take the form of a defined assignment, ongoing advisory involvement or additional capacity during a demanding stage of the study. We agree clear responsibilities, deliverables and communication arrangements so that our experts work effectively with your team and existing partners.
Audit & Quality
Understand the gaps. Strengthen study quality
Effective quality management helps protect participants, support reliable data and maintain control over clinical research activities. We help sponsors, biotech companies, CROs and research sites assess their processes, identify weaknesses and prioritise improvements.
Our support ranges from a focused review of a specific concern to a broader assessment of study activities or organisational readiness. Each assignment is tailored to the project, its risks and the responsibilities of the organisation being assessed.
Research site audits
We assess how clinical studies are conducted and documented at research sites. Depending on the agreed scope, this may include informed consent, eligibility assessment, protocol adherence, source documentation, investigational product accountability, safety reporting processes and investigator oversight.
Our team combines clinical research and medical practice experience with practical knowledge of site operations, helping us assess both the findings and the circumstances behind them.
Sponsor and CRO process reviews
We review the processes used to organise, manage and oversee clinical studies. Areas of focus may include allocation of responsibilities, delegated activities, vendor oversight, document management, staff training and the handling of issues requiring escalation.
We help identify gaps between documented procedures and day-to-day practice, with recommendations proportionate to the organisation’s size and study portfolio.
Study-specific quality assessments
When concerns arise during a study, we provide targeted assessments of the affected activities, documentation or processes. We help establish the extent of the issue, consider its potential impact on participant protection and data reliability, and identify priorities for further action.
Audit and inspection readiness
We help teams prepare for sponsor audits and regulatory inspections through readiness reviews, documentation checks and preparation of relevant personnel. Our focus is on identifying unresolved issues, ensuring that records are accessible and consistent, and helping staff explain their responsibilities and working practices clearly.
Corrective and preventive actions
We support the investigation of root causes and the development of corrective and preventive action plans. We help define actions, owners, deadlines and evidence of completion, together with a practical approach to assessing whether the measures have been effective.
Procedures and team development
We help organisations develop or improve standard operating procedures, working instructions and training tailored to their activities. Our aim is to make quality requirements understandable and usable in everyday work, with clear responsibilities and proportionate controls.
Clear findings and practical next steps
Our assessments provide a structured account of findings, their significance and recommended priorities. Where requested, we can support the implementation of improvements as a separate follow-up assignment.
When audit and consulting services are combined, we agree arrangements to manage conflicts of interest and preserve the independence of the assessment, including separate reviewers where appropriate.
Legal Support
Clear agreements. Defined responsibilities. Informed decisions
Clinical research brings together sponsors, CROs, investigators, research sites and specialist providers, often across several countries. We help these parties establish clear contractual arrangements and address the legal questions that arise when preparing, conducting and completing a clinical study.
Legal services are provided by our collaborating legal counsel and law firm, working alongside our clinical and operational experts. This allows legal advice to reflect both the requirements of the project and the practical realities of study delivery.
Clinical study agreements
We support the drafting, review and negotiation of agreements between sponsors, CROs, research sites and investigators. We help define the scope of work, responsibilities, payment terms, timelines and arrangements for changes or early termination.
Our review also addresses matters such as liability, insurance provisions, confidentiality, intellectual property, publication rights and access to study documentation.
International contracts and negotiations
We assist with cross-border agreements and negotiations involving sponsors, CROs and other clinical research partners. We help identify contractual risks, clarify governing law and dispute resolution provisions, and coordinate input from local counsel where jurisdiction-specific advice is needed.
Our aim is to reach workable agreements that reflect the intended collaboration and allocate responsibilities clearly.
Vendor and subcontractor agreements
We prepare and review agreements with laboratories, consultants and other service providers involved in a study. We help ensure that delegated activities, deliverables, oversight arrangements and escalation obligations are clearly described and consistent with the wider contractual framework.
Regulatory and local legal advice
We provide legal advice on the EU Clinical Trials Regulation and applicable national requirements relevant to medicinal product studies. We help clients assess how these requirements affect their responsibilities, agreements and planned activities.
Where a project also involves medical devices, our collaborating legal counsel can advise on relevant MDR aspects and the interaction between the applicable frameworks.
EU legal representation for sponsors
Through our collaborating law firm, we offer EU legal representation for sponsors established outside the EU where required for their clinical trials. The scope of representation, responsibilities and communication arrangements are assessed for the particular project and defined in a separate agreement with the law firm.
Legal support during study delivery
We assist with contract amendments, changes in scope, payment issues, delays and disagreements between study partners. We help clients assess their contractual position, prepare correspondence and negotiate practical solutions while considering the implications for ongoing study activities.
Legal expertise integrated with your project
Support can cover a single agreement, a specific negotiation or continuing legal advice throughout a study. We agree the scope of involvement at the outset and coordinate legal, clinical and operational input so that decisions are informed by the full context of the project.
