CRO-Solutions
CRO-Solutions®, an IQVIA business, is a clinical research organization based in Manchester, UK, providing a comprehensive range of clinical trial services including regulatory services, protocol writing, clinical monitoring, data management, pharmacovigilance, medical monitoring, biostatistics, medical writing, TMF management, and central services. The company emphasizes flexible, responsive teams, high-quality and compliant trial execution, and close collaboration with clients to support efficient and effective clinical research in respiratory, dermatological, and cardiovascular medicine.
Industries
Nr. of Employees
medium (51-250)
CRO-Solutions
Salford, Oxfordshire, United Kingdom, Europe
Services
End-to-end project leadership, regulatory planning and submission support, stakeholder coordination and global trial delivery.
Protocol development with integrated clinical pharmacology, safety planning and recruitment strategy informed by clinical specialists.
On-site and remote monitoring, blinded/unblinded monitoring, feasibility assessments and independent monitoring consultancy.
Design and build of CDASH-compliant eCRFs, EDC configuration, external data reconciliation and database lock processes.
Safety project management, SMP development, ICSR handling and periodic/expedited regulatory reporting including DSUR preparation.
Provision of medical monitors for document review, eligibility oversight, AE/SAE assessment and narrative sign-off.
End-to-end project leadership, regulatory planning and submission support, stakeholder coordination and global trial delivery.
Protocol development with integrated clinical pharmacology, safety planning and recruitment strategy informed by clinical specialists.
On-site and remote monitoring, blinded/unblinded monitoring, feasibility assessments and independent monitoring consultancy.
Design and build of CDASH-compliant eCRFs, EDC configuration, external data reconciliation and database lock processes.
Safety project management, SMP development, ICSR handling and periodic/expedited regulatory reporting including DSUR preparation.
Provision of medical monitors for document review, eligibility oversight, AE/SAE assessment and narrative sign-off.
Expertise Areas
- Clinical trial management
- Regulatory submissions and ethics
- Protocol design and clinical pharmacology
- Clinical monitoring and site oversight
Key Technologies
- CDASH-compliant electronic case report forms (eCRFs)
- Electronic data capture (EDC) systems
- CDISC SDTM and ADaM datasets
- Multiplex immunoassays (plate-based)
News & Updates
Partnership announcement with ARXX Therapeutics.
Kinaset Therapeutics reports dosing in its Phase 1b study.
CRO Solutions reports the first patient dosed in a COVID-19 related trial.
Partnership announcement with DICE Therapeutics.
Kinaset Therapeutics reports dosing in its Phase 1b study.
Partnership announcement with ARXX Therapeutics.
Kinaset Therapeutics reports dosing in its Phase 1b study.
CRO Solutions reports the first patient dosed in a COVID-19 related trial.
Partnership announcement with DICE Therapeutics.
Kinaset Therapeutics reports dosing in its Phase 1b study.