Clinical Development
We design clinical strategies and programs, support with Scientific Advice, write protocols, prepare and submit CTAs and INDs, manage CRO and site operations, and compile the clinical sections of the MAA dossier, ODDs, PIPs and others. For non-EU sponsors, we act as EU legal representative or take on the full sponsor role, carrying the legal responsibility for the trial, but also prepare the CTA application, do safety reporting, and take care of GCP compliance. Our clinical team works alongside our regulatory, CMC, and pharmacovigilance experts to ensure consistency across all regulatory documents.
Examples of How We Support
These are just examples to illustrate the kind of work we do day to day. The fastest way is usually a short call to understand your situation and discuss how we can help.
Clinical program design
You have a compound entering clinical development and need a clinical program designed from the ground up: indication strategy, trial design, endpoint selection, protocol authoring, and a clear plan for how the clinical evidence feeds into regulatory expectations.
EU trial sponsor representation
You are a non-EU sponsor and need to run a clinical trial in Europe. Under the EU Clinical Trials Regulation (CTR), you either need an EU legal representative or someone to act as the trial sponsor in the EU. You need a partner who can submit the CTA via CTIS, manage the regulatory interactions with member state authorities, carry the insurance obligations, and ensure GCP compliance across your EU sites.
CTA or IND preparation
You need to prepare a CTA or IND and the clinical documentation is not submission-ready, for example the protocol needs finalising and the investigator's brochure needs updating.
Trial course correction
Your clinical program is running but you are facing challenges: a protocol amendment is needed, an authority has raised concerns, interim data are not aligning with expectation, or HTA considerations are forcing changes to the evidence generation plan.
Device and IVD clinical studies
You need to design a clinical investigation or performance study for a medical device or IVD under MDR or IVDR, including the clinical investigation plan, CTA, and sponsor oversight.
Understanding Clinical Development
When we talk about clinical development, we mean strategic consultation and operational work that is the basis for generating the clinical evidence needed for regulatory approval: strategic program design, protocol authoring, CTA submission and authority interactions, Scientific Advice preparation, trial operations management, authority interactions. We do not operate our own clinical trial sites, run our own labs, or provide biostatistics services in-house. When trials need CROs, sites, central labs, or statisticians, we select, qualify, and manage them.
What distinguishes our approach is integration with the regulatory submission. The same team that initially designs the clinical programme also later writes CTD Modules 2.5, 2.7, and 5, compiles the submission, and handles the authority interactions. This means benefitting from a deep understanding of all phases and tasks throughout development. For the regulatory submission and dossier compilation work itself, see Regulatory Strategy & Operations. For the medical and scientific writing of clinical documents, see Medical & Scientific Writing.
What We Do
Clinical development work spans from early programme design through to the clinical content of the marketing application. Here's what we deliver in practice:
Our Workstreams
Clinical development engagements typically combine several of these workstreams. The scope depends on whether you need programme-level strategy, trial-level execution, or both.
Clinical Programme Strategy
Indication and endpoint selection. Cross-regional development roadmaps (EU/US/Japan). Feasibility and gap analyses. Orphan and paediatric strategy (ODD applications, PIP drafting and negotiation). Scientific advice preparation for clinical questions.
Protocol Design & Trial Planning
Study synopses and full protocols. Decentralised and hybrid trial design elements per ICH E6(R3). Digital endpoint selection and remote data capture via ClinSense. Investigator's brochure authoring. Statistical considerations and SAP inputs. Informed consent form development.
Trial Operations & CRO Management
CTA/IND submission and management via CTIS and national portals. CRO and site selection, qualification, and oversight. Trial Master File setup and maintenance. Safety reporting coordination. Protocol amendment management. UK CTA submission via IRAS and combined review coordination with MHRA and Research Ethics Committee.
Sponsor & Legal Representation
Full EU sponsor role under the CTR: CTA application, trial insurance, safety reporting, GCP compliance, and authority correspondence. EU legal representative services for non-EU sponsors. Responsible for trial conduct in the EU on the sponsor's behalf.
Clinical Dossier Authoring
Clinical overviews and summaries for MAA/NDA. Integrated benefit-risk narratives. Responses to authority questions on clinical data.
Device Clinical Investigations
Clinical investigation plans (CIPs) under MDR Article 62. Performance study protocols under IVDR Chapter VI, including analytical and clinical performance studies for Class C and D IVDs. Ethics committee and competent authority submissions. Notified Body alignment on clinical evidence strategy and endpoints. Clinical evaluation report (CER) and performance evaluation report (PER) input from prospective studies. PMCF and PMPF study design for post-market evidence generation.
Clinical Investigation Plan (CIP) for a Medical Device Under MDR. Where This Fits in the Development Journey
Clinical development activities span multiple phases but the intensity and nature of the work shifts.
Discovery & Concept
Assess clinical feasibility. Identify potential endpoints and evidence requirements. Evaluate whether orphan, paediatric, or accelerated pathways apply.
Preclinical
Plan first-in-human studies in parallel with nonclinical work. Draft preliminary protocols. Coordinate scientific advice on clinical questions.
Design & Development
Develop detailed study designs, statistical plans, and protocols. Author investigator’s brochures. Prepare and submit PIP and ODD applications. Coordinate CRO selection.
Clinical
Execute trials: submit CTAs via CTIS, manage CROs and sites, oversee data collection and safety reporting, handle protocol amendments. Act as sponsor or legal representative for EU trials.
Regulatory Submission & Approval
Compile CTD Modules 2.5, 2.7, and 5. Respond to authority questions on clinical data. Coordinate HTA evidence packages with partners.
Post-Market & Lifecycle Management
Design post-authorisation efficacy studies (PAES), PMCF studies for devices, and variation-supporting clinical studies. Manage new indication programmes.
Product Type Considerations
Clinical development requirements differ substantially depending on what you're developing. The trial designs, regulatory pathways, and evidence expectations vary by product type.
Small Molecules
Established Phase I–III pathway. Focus on dose-finding, PK/PD, pivotal efficacy, and safety. Bioequivalence and bridging studies for generics and reformulations. Scientific advice timing is critical for pivotal study design.
Medical Devices
Clinical investigations under MDR Article 62 or IVDR Chapter VI. Performance study design. PMCF studies for post-market evidence generation. Clinical evaluation reports (CERs) integrating literature and clinical data. Notified Body interaction on clinical evidence strategy.
Combination Products
Clinical programme must address both the drug and device components. Human factors studies alongside clinical efficacy trials. Primary mode of action determines the lead regulatory pathway and the clinical evidence requirements.
Biologics & ATMPs
Longer development timelines. Comparability and immunogenicity affect clinical design. For ATMPs, surrogate endpoints and small patient populations require adaptive or single-arm designs. PRIME and RMAT designations can accelerate development.
Digital Health & SaMD
Clinical validation studies to demonstrate clinical benefit. Endpoint selection for software-based interventions. Digital endpoint capture and remote monitoring via ClinSense. For prescription digital therapeutics (PDTs), clinical evidence requirements align with DiGA/DiPA evaluation criteria in Germany.
Sample Deliverables
These are typical outputs from our clinical development engagements.
Integrated clinical development plan with indication prioritisation, trial sequencing, endpoint strategy, and regulatory milestone mapping. 
Clinical study protocol with ICH E6(R3)-aligned quality management approach, risk assessment, and (where applicable) decentralised trial elements. Gap analysis of US data package and proposal for aligning with EU regulatory expectations. Scientific Advice procedure. Investigator’s brochure (new or updated) compiled from nonclinical, CMC, and clinical data. 
CTA application package submitted via CTIS, including Part I and Part II documentation, cover letters, and member state-specific requirements. 
UK CTA application package submitted via IRAS, including MHRA and Research Ethics Committee documentation. 
Orphan drug designation dossier demonstrating prevalence and significant benefit, with supporting nonclinical and clinical evidence. 
Paediatric investigation plan (PIP) with proposed studies, age-group stratification, waiver/deferral justifications, and PDCO submission package. CTD Modules 2.5, 2.7, and Module 5 (Clinical Overview, Clinical Summary, and Clinical Study Reports) for MAA or NDA submission. Example Projects
Illustrative Example
EU Biotech: Full Clinical Programme Design and CTA for a Rare Disease
A small biotech with a novel compound for a rare metabolic disorder needed a complete clinical programme. We designed the development plan (Phase I/II adaptive design), prepared the orphan designation dossier (granted by EMA), drafted the PIP, authored the protocol and investigator's brochure, submitted the CTA via CTIS across three EU member states, and provided ongoing trial management. The CTA was approved without major objections in all three countries.
Illustrative Example
US Pharma: EU Sponsor Services for a Multi-Country Phase III Trial
A US pharmaceutical company needed to run a Phase III trial in four EU countries but had no EU presence. We took on the full EU sponsor role under the CTR: submitted the CTA via CTIS, arranged trial insurance, managed safety reporting to EudraVigilance, and served as the regulatory contact for all four national competent authorities. We also selected and oversaw the EU CRO. The sponsor maintained scientific oversight while we handled all EU regulatory and operational obligations.
Illustrative Example
Medical Device Company: Clinical Investigation under MDR for a Class III Implant
A device manufacturer needed a prospective clinical investigation to support MDR conformity assessment for a Class III implantable device. We designed the clinical investigation plan, prepared ethics committee submissions across two EU countries, coordinated with the Notified Body on endpoints and study design, managed site setup and monitoring, and compiled the clinical data into the CER. The Notified Body accepted the clinical evidence without requesting additional studies.
Designing a clinical programme, preparing a CTA, or need EU sponsor services for your trial?
Tell us about your product and timeline, and we’ll outline how we can help.
Speak with an ExpertKey Regulations & Guidance
These frameworks govern clinical trial conduct and clinical evidence requirements across our work.
Frequently Asked Questions (FAQ)
What does it mean when you “act as sponsor” for an EU clinical trial?
Under the EU Clinical Trials Regulation, the sponsor is the individual or organisation that takes legal responsibility for initiating, managing, and financing the trial. When we act as sponsor, we submit the CTA via CTIS under our name, arrange trial insurance and indemnity coverage, report suspected unexpected serious adverse reactions (SUSARs) to EudraVigilance, ensure GCP compliance across all sites, and serve as the regulatory contact for national competent authorities. The client (typically the product developer) retains scientific oversight and funds the trial, but the formal regulatory and legal obligations in the EU sit with us. This is not the same as being a CRO: a CRO performs delegated tasks, while the sponsor carries the ultimate legal responsibility.
What is the difference between an EU sponsor and an EU legal representative?
If you're a non-EU company, the CTR requires you to either have a sponsor established in the EU or designate an EU legal representative. As legal representative, we act as your contact point for EU authorities and ensure that the sponsor's obligations under the CTR can be enforced in the EU, but the sponsor retains overall responsibility. When we act as the sponsor itself, we take on the full set of obligations. The right choice depends on your internal capacity, risk appetite, and how much of the EU regulatory burden you want to carry.
How has ICH E6(R3) changed how you design trials?
ICH E6(R3) was finalised in January 2025 and became effective in the EU in July 2025. The biggest practical changes are the emphasis on quality by design (identifying “critical to quality” factors upfront), proportionate monitoring (risk-based rather than 100% source data verification), and formal recognition of decentralised trial elements (remote consent, home delivery of IMP, wearable data capture). We design protocols with these principles built in, which means proportionate oversight plans and quality management systems are part of the protocol package, not afterthoughts.
Do you handle CTIS submissions?
Yes. All new EU clinical trial applications must go through CTIS since 31 January 2023, and all ongoing trials were required to transition by 31 January 2025. We prepare and submit CTA applications, substantial modifications, and notifications through CTIS. We also manage the Part I/Part II documentation split, handle requests for information from member states, and coordinate the assessment process across reporting and concerned member states.
Can you design clinical investigations for medical devices under MDR?
Yes. We design clinical investigation plans (CIPs) under MDR Article 62, prepare ethics committee and competent authority submissions, coordinate with Notified Bodies on clinical evidence strategy, and manage site operations. For IVDs under IVDR, we design performance studies. We also support PMCF study design for post-market evidence generation and integrate prospective clinical data into CERs and performance evaluation reports (PERs).
How does ISO 14155 apply to device clinical investigations?
ISO 14155 is the international standard for good clinical practice in medical device clinical investigations, equivalent to ICH E6 for pharmaceutical trials. It defines the requirements for investigation planning, conduct, recording, and reporting. Our device clinical investigation work follows ISO 14155, and we ensure that CIPs, ethics submissions, and monitoring activities are aligned with its requirements. For investigations submitted under MDR Article 62, compliance with ISO 14155 is a regulatory expectation referenced directly in the regulation.
When should HTA considerations be integrated into clinical design?
Now. The EU HTA Regulation has been operational since January 2025, with Joint Clinical Assessments (JCAs) already running for oncology products and ATMPs. From 2026, selected high-risk medical devices are in scope. The PICO framework used for JCAs (Population, Intervention, Comparator, Outcomes) should be considered when designing pivotal studies, particularly comparator selection and outcome measures. We work with dedicated HTA partners to align clinical evidence with both regulatory and payer requirements.
Do you run clinical trials directly, or do you manage CROs?
We do not operate our own trial sites or in-house labs. When a trial needs operational execution (site monitoring, data management, biostatistics, central lab services), we select, qualify, and manage CROs and service providers. We write the RFPs, evaluate bids, negotiate contracts, and provide oversight. What we do directly: programme design, protocol authoring, regulatory submissions, sponsor representation, authority interactions, and clinical dossier compilation.