First-in-human may be further away than you think
Teams that believe they are ready for first-in-human can still be 12 to 18 months away. The gap is rarely in the science. Formulation, manufacturing, stability work or the toxicology package may not yet support the clinical design. Clarenta identifies these gaps early and helps you build a practical path towards first-in-human.
Strengthen your biotech programme at every critical step
If you already have a development plan, internal expertise or selected partners, you may need additional capacity or specialist guidance at a critical stage. Clarenta can strengthen specific parts of your programme, challenge assumptions and connect strategy with execution, without disrupting the model you already have in place.
Biotech & Pharma Clients
Biotech CRO support across the development pathway
We connect CMC, non-clinical, regulatory and clinical planning so each decision supports the next. Our teams can help define the development strategy, identify gaps and risks, prepare realistic timelines and budgets, and provide the scientific and operational oversight needed throughout the programme.
- Non-clinical package review, gap analysis and risk assessment
- EU, CTIS and UK regulatory strategy and submissions
- Protocol, endpoint, country and site planning
- First-in-Human and Phase I/II studies, including delivery in our Sofia unit
- Clinical Operations, Biometrics and Medical Writing through Phase III across Europe
A biotech partnership built around your team
Biotech companies come to us at different stages and with different levels of internal capacity. We shape our role around the expertise you already have in place and adapt our support as your programme progresses.
Development strategy & consulting
Senior scientific and regulatory input helps shape the decisions behind your programme, from non-clinical requirements and starting-dose justification to regulatory strategy and First-in-Human study design.
Full-service clinical trial delivery
We deliver studies across 24 European countries, bringing start-up, site management, monitoring, data management, biostatistics, pharmacovigilance, Regulatory Affairs and Medical Writing within one accountable team.
Phase I Unit support
Our Phase I Unit in Sofia supports studies in healthy volunteers and patients, with experienced clinical teams and an integrated bioanalytical laboratory.
What our clients say
Case study: First-in-Human immuno-oncology across Europe and the US
A European immuno-oncology biotech needed to deliver its first Phase I/IIa study across Europe and the US while building its internal Clinical Operations capability. Clarenta supported study design, led European submissions and delivery, coordinated specialist partners, and oversaw the US CRO.
The European submission was completed within two weeks of the final protocol, with the first patient enrolled on schedule. Clarenta recruited 262 patients across Europe and was subsequently awarded a second study.