Accountability built into every CRO partnership
When delivery is subcontracted, accountability does not disappear. Your partner must be operationally capable, inspection-ready and easy to integrate from the outset.
Clarenta is built to be your dependable partner: clear responsibilities, documented quality systems, local teams and delivery aligned to your SOPs, systems and reporting requirements.
Clear partnership solutions for complex delivery gaps
Problem: You carry the risk for work you do not perform
When a subcontracted partner falls short, the consequences reach your organisation and your sponsor relationship. Unclear responsibilities and escalation routes can create as much risk as poor delivery.
Solution: Review the evidence before you commit
Our quality framework aligns with ICH-GCP and GCLP requirements. Qualification documentation is available before contracting, while decision rights, responsibilities and escalation routes are defined clearly.
Problem: Your study reaches beyond your operational footprint
Entering countries where you lack local infrastructure, regulatory knowledge or established site relationships can slow feasibility, start-up and delivery.
Solution: Extend your reach through established local teams
Clarenta takes responsibility for defined countries, providing local regulatory support, site access and clinical operations within your existing study model. Gain the coverage without the infrastructure.
Problem: Capacity gaps can put the wider study under pressure
Changing timelines, competing studies or unexpected recruitment demands can leave critical functions without enough operational support.
Solution: Add capacity where the pressure is greatest
We provide clearly scoped functional support across Clinical Operations, Regulatory Affairs, project management and other defined activities. Our teams work within your systems and reporting structure.
Problem: Specialist early phase work falls outside your core capabilities
A study may require a dedicated Phase I setting, intensive PK sampling or access to specific patient populations that your existing network cannot provide.
Solution: Bring specialised capability into your delivery model
Clarenta adds early phase expertise, operational infrastructure and access to our Sofia Early Phase Unit while you retain oversight of the wider study and the sponsor relationship.
Problem: Local underperformance can threaten the wider study plan
Slow start-up, weak recruitment or underperforming sites in one region can affect milestones across an otherwise well-managed trial.
Solution: Address the issue where it begins
Our local teams identify the operational causes, strengthen site support and implement corrective actions within your governance structure. You retain visibility while we focus on returning all activities to plan.
CRO partnership capabilities that strengthen your delivery model
Where we deliver
In-country regulatory teams based in markets outside CTIS, with established national submission routes
Extended network across additional European markets, with centralised regulatory services
What we deliver
Feasibility, recruitment support and data functions as a defined scope
First-in-human, complex early development and bioequivalence studies in our own unit
Depth in oncology, rare diseases, dermatology, gastroenterology and hepatology, respiratory disease, neurology and cardiology
How we integrate
Defined ownership, decision rights and escalation routes before start-up
ISO 9001:2015 certified, with a GCLP-accredited clinical laboratory
Quality and compliance functions independent of operational delivery
Qualification documentation available for partner review and ongoing oversight
Our CRO partners
29 years working alongside CRO partners
- You decide how the partnership appears to the sponsor: We operate as a named regional partner or entirely within your branding, systems and reporting structure. Appointing us does not put a second organisation in front of your client. That decision is made in the work order, before delivery begins, and it does not change unless you change it.
- We work inside your systems, not alongside them: A partner that arrives with its own CTMS, its own reporting formats and its own quality processes creates an integration problem before it creates any capacity. Our teams are trained into your SOPs, systems and reporting conventions, so added delivery capacity does not become added oversight work for your vendor management team.
Local knowledge behind every feasibility decision
- Pan-European reach, backed by local infrastructure: We hold direct operational presence in 24 countries across Western, Central and Eastern Europe, the Baltics, the Caucasus and Central Asia. Several of those operate outside the EU Clinical Trials Information System and follow their own national regulatory and ethics pathways. Our in-country regulatory teams bring established submission routes and practical authority experience in exactly the markets where holding your own infrastructure is hard to justify for a single study.
- Feasibility comes from the teams who will deliver: Country and site assessments come from local operational knowledge, investigator relationships and realistic recruitment potential, not from generic country assumptions applied at a distance. The people making the estimate are the people who will have to meet it.
Five ways we support CRO partners
Flexible support where you need it
Use the model that fits the gap. You may need one country, one function, specialist early phase capacity, or a study stabilised. We take responsibility for the defined scope and leave the rest of your delivery model intact.
Regional and country-level delivery
We take responsibility for defined countries within your study, covering regulatory submissions, site identification and management, monitoring and local clinical operations. The study-level model stays yours.
Functional support
Where the gap is a function rather than a geography, we provide clinical operations, feasibility, site identification, recruitment support, regulatory affairs or data functions as a defined scope inside your delivery model.
Early phase capacity
First-in-human, complex early development and bioequivalence studies in our own unit, either as a standalone programme or as additional capacity alongside your own.
Rescue and study optimisation
Where a study is already behind plan, we identify the operational constraint and take responsibility for the countries, functions or activities needed to stabilise delivery.
An Early Phase Unit built for accountable delivery
Our Early Phase Clinical Research Unit in Sofia runs first-in-human, complex early development and bioequivalence studies. The facility brings clinical operations, an on-site pharmacy and a clinical laboratory into one environment, while external bioanalytical laboratories are coordinated according to study requirements. The unit has been inspected by both the FDA and the EMA.
When delivery is subcontracted, accountability does not disappear. Your partner must be operationally capable, inspection-ready and easy to integrate from the outset.
Clarenta is build to be your defensible partner: clear responsibilities, documented quality systems, local teams and delivery aligned to your SOPs, systems and reporting requirements.
Let’s discuss where you need support
FAQs
Yes. Several markets in our footprint operate their own national submission processes outside the EU Clinical Trials Information System, and our regulatory teams are resident in those countries. Coverage in non-CTIS markets is one of the most common reasons a partner CRO engages us.
Through a Master Service Agreement with one or more project-specific work orders. Each defines scope and division of responsibilities, deliverables and timelines, governance and communication processes, quality and reporting requirements, escalation pathways, and financial terms. Arrangements range from single-project collaboration to preferred-provider relationships.
Clarenta provides qualification documentation for partner review, including our quality framework, training records, audit readiness and inspection history. Our credentials include ISO 9001:2015 certification, FDA No Action Indicated status and GCLP accreditation. Documents issued before the rebrand remain under the Comac Medical name.
Certifications