Our services
We offer the full range of clinical development and clinical operations services
At CR2O, we have a highly motivated and experienced cross-functional team that helps you to effectively bring your project to the clinic. Our integrated project teams enable seamless transition between the domains we service. CR2O team members undergo continuous training throughout their careers at CR2O to ensure we support our projects in the best possible way. All our subcontractors are qualified per CR2O SOPs.
Product Development
Program Management
We bring world-class experts together and manage cutting-edge programs to bring innovative therapies to those in need.
- Grant proposal development
- Financial program management
- Scientific program management
- Governance and communication
- Sponsor representative
- Dissemination and valorization
Non-clinical
- Advice on non-clinical development strategy
- CRO selection and contract negotiation
- Coordination of toxicology studies
- In vitro & in vivo DMPK / toxicology
- Analysis of regulatory pathways
- Interpretation of non-clinical data and writing preclinical study reports
- Target relevance and druggability
- Non-clinical GLP safety pharmacology
- Design of in vitro and in vivo studies
- Review of non-clinical data in conjunction with regulatory framework
- In vitro & in vivo disease models
Chemistry, Manufacturing and Controls (CMC)
Our CMC experts support you in defining a CMC strategy resulting in a robust manufacturing process.
- Drug product development strategy
- Formulation development and stability testing
- CMC leadership
- Analytical methods and characterization
- CDMO selection
- Quality by design
Regulatory
Our team of former regulators offer early development strategies from proof of concept to marketing application (MAA or NDA).
- Regulatory strategy
- Support health authority interaction
- Target product profile development
- eCTD, reports, and submission documents
- Support scientific advice
Strategic R&D planning
Our experts support you in navigating the complex journey from benchtop research to successful commercialisation.
- Strategic Project Management through preclinical and clinical development
- Resources allocation and optimisation
- Governance structure development
- Stakeholder engagement
- Risk management
Commerciaisation
Our strategic market access and commercial experts offer you deep market insights and access to
global networks to give you the best chance of swift and impactful commercialisation.
- Commercialisation workshop
- Market access / reimbursement
- Investor pitch decks
- Market positioning strategy
- KoL mapping and engagement
- Financial and economic modelling and analytics
- Competitive landscape assessment
- Funding strategies
Quality
Our scalable solutions are offering high standards of compliance, privacy & security in all GxP disciplines.
- Inspection readiness
- GDPR compliance
- Training and advice
e.g. On ICH E6 GCP guidelines and GCP-related laws and regulations
- Auditing
- Support and advice on the development of your GCP-based QMS
Clinical Operations
Clinical Trial Management
From trial synopsis development up to finalization of the clinical report, we are here for you from start to finish of your trial.
- Global trial management
- Clinical monitoring
- Clinical operations plans and manuals
e.g. Project plans, Communication plans, Operational plans, Monitoring plans
- Study feasibility and site selection
Data Management
We transform data into knowledge, using state-of-the-art Electronic Data Capturing systems.
- Development of data management plan
- User acceptance testing of eCRF and validation checks
- Integration of electronic data from central lab in the eCRF
- Database lock and data exports
- Perform power calculation and provide statistical input on the protocol
- CDISC/ADAM conversion
- Development of data validation plan
- eCRF training for users
- Coding of medical terminology
e.g. Adverse events, medical history, medications
- Development of statistical analysis plan
- Development, validation, and documentation of SAS programs
- Generation of statistical reports
- eCRF design and setup
- Continuous data review (including query management)
- Serious adverse event reconciliation between eCRF and safety database
- Development of randomization listings
- Development of specifications for analysis datasets
e.g. Tables, listing, figures
Biostatistics
Our biostatisticians use the latest insights for analysis, interpretation and presentation of data ensuring traceability, reproducibility and compatibility across studies.
- Perform power calculation and provide statistical input on the protocol
- Development, validation, and documentation of SAS programs
- Generation of statistical reports
- Development of statistical analysis plan
- CDISC/ADAM conversion
- Development of randomization listings
- Development of specifications for analysis datasets
e.g. Tables, listing, figures
Safety Management & Medical Monitoring
We ensure safety is properly managed throughout the lifecycle of your programs.
- Global drug safety project management
- Eudravigilance setup and management
- Six-monthly and quarterly reporting to competent authorities and ethics committees
- Setup and management of DSMB
- Expedited reporting to competent authorities, ethics committees, and investigator sites
- Electronic management of SAEs on the safety database
- Signal detection
- Medical oversight of clinical trials
- Responsible person for Eudravigilance oversight
- Reconciliation with clinical database
- Preparation and distribution of DSURs
- Coding of medical terminology
Insourcing
We ensure you can take advantage of professionals with diverse backgrounds, expertise, and international contacts.
- Trained life science professionals
- Individuals or teams
- Flexible staffing models
- Diverse backgrounds and expertise
- Flexible contract durations
- Flexible staff locations
Regulatory Submissions
From design to approval of your clinical trial.
- Translation of guidelines / regulatory requirements into clinical trial designs
- Submission of Periodic Updates and End of Trial Notifications
- Development, review, and approval of all essential clinical trial documents.
- Submissions to competent authorities and IECs/IRBs
Medical & Scientific Writing
Our medical writers transform complex ideas into concise documents that prove to be essential to publish reliable research data.
- Trial Synopsis
- Investigational Medicinal Product Dossier
- Clinical Study Protocol
- Clinical Study Report
- Trial Synopsis Clinical Study Protocol Investigator's Brochure
- Scientific Publications