Services

Feasibility assessment and site selection

We offer a comprehensive feasibility assessment (study/country/site feasibility) in Poland, the Czech Republic, and Slovakia. Within a short timeframe, we identify sites and Investigators that meet protocol requirements and support the patient recruitment and retention plan.

• Feasibility assessment at the country and site level (site feasibility)
• Investigator and site selection (Investigator/Site selection)
• Recommendations on patient recruitment and retention strategy
• Support in planning site activation and the start-up timeline

Contracts: preparation, negotiation, and execution

Our legal team prepares, negotiates, and ultimately finalizes contracts with sites, Investigators, and vendors (vendor contracts) – efficiently and in a structured manner, to avoid delaying study start.

• Drafting of agreements (site/investigator/vendor)
• Negotiation of terms and coordination of document flow
• Support for the signature process and compilation of start-up documentation

Phase I–IV medicinal product trial monitoring and site management

We provide Phase I–IV medicinal product trial monitoring with ongoing site support (site management), tailoring our approach to the protocol requirements and the Sponsor’s operating model.

• Visits: pre-study, initiation, monitoring, close-out
• Ongoing site support and resolution of operational issues
• Remote monitoring and risk-based monitoring (RBM)
• Organization of kick-off meetings and investigators’ meetings
• Project management delivered by the CRO

Medical device clinical investigations

We provide operational support for medical device clinical investigations, including complex and high-risk projects. Our documented experience in this area dates back to 2008.

• Feasibility and selection of Investigators and sites with relevant procedural experience
• Support for start-up and the required regulatory and ethics processes
• Monitoring, site management, recruitment support and document oversight
• Pilot, pivotal and post-market investigations, depending on the device development stage
• Work aligned with current regulatory requirements and applicable quality standards, including ISO 14155:2020

Patient recruitment and retention

We support the project in developing a patient recruitment and retention strategy, in close collaboration with sites and Investigators (including KOLs), to achieve recruitment targets and minimize the risk of delays.

• Recommendations on recruitment strategy and retention activities
• Operational support to sites in implementing the recruitment plan

Participant expense reimbursement and compensation

We organize and manage expense reimbursement and other approved payments to study participants in medicinal product trials and medical device investigations.

• Study- and country-appropriate arrangements aligned with the protocol, participant documents and approvals
• Collection and verification of claims and execution of payments
• Coordination of tax, data protection and financial documentation requirements
• Reporting and a complete audit trail

Start-up and CTR (CTIS) regulatory process

We provide comprehensive regulatory support in line with EU Regulation 536/2014 (CTR), including end-to-end management of the Clinical Trials Information System (CTIS) – the EU portal for clinical trial submissions and trial lifecycle management across the EU/EEA.

• Preparation and submission of the clinical trial application via a single submission in CTIS (CTR)
• Compilation and verification of the dossier in accordance with CTR requirements (including documentation for the joint assessment and the national part)
• Ongoing communication and correspondence handling in CTIS (questions/clarifications, updates, timelines)
• CTIS trial lifecycle management: substantial modifications, updates, reporting, and document management within the system
• Translations, localization, and adaptation of documents to national requirements (if applicable)
• EU Legal Representation* for Sponsors established outside the European Union – acting as the legal representative in the EU, including formal support in the submission process and communication under CTR/CTIS (scope as agreed within the project)

*Legal Representative for non-EU Sponsors (EU Legal Representation)

If the Sponsor is established outside the European Union, we can provide EU Legal Representation. In practice, this means dedicated formal, legal, and operational support to meet CTR requirements, including handling CTIS processes, ensuring that trial authorization and trial management are conducted smoothly and in structured manner.

Pharmacovigilance (PV) and Medical Monitoring

We provide support in the safety area: fulfillment of reporting obligations, oversight of SAEs, and medical support throughout the entire study.

Pharmacovigilance (PV):

• Coordination of safety reporting in accordance with GCP
• Review of SAEs for completeness and accuracy
• Preparation and management of reports (including CIOMS)
• Submissions to relevant authorities and systems (including EudraVigilance)

Medical Monitoring:

• Medical review and assessment of SAEs
• Protocol-related medical support and ongoing safety oversight

Audits and inspections: coordination and support

We coordinate and support sponsor audits and regulatory inspections at sites, including preparation, communication, and follow-up activities.

• Preparation of sites for an audit/inspection
• Support during the audit/inspection and coordination of responses
• Oversight of post-audit activities (CAPA – if within scope)

Translation and localization of documentation

We provide translation, localization, and adaptation of study documentation and regulatory documents to meet national and site requirements.

• Translation of study documents and regulatory submission packages
• Content localization (terminology, formats, national requirements)
• Support in preparing versions for sites and study participants

Staff outsourcing (contract hire) and recruitment

We provide contract-based resources (e.g., CTA/CRA/Lead CRA/SCRA) or manage the recruitment process for external companies – depending on project and organizational needs.

• Contract hire: temporary team support (clinical operations, start-up, administration)
• Flexible engagement model: for a fixed term or for delivery of a specific task
• Recruitment on demand: managing the selection process and recommending candidates

GCP training and Brillance Academy

In addition to operational services, we provide GCP training and practical clinical research courses for Investigators, site teams, Sponsors and CROs.

Our programs combine current requirements with real-world examples and workshop-based learning. View training programs and dates.