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.

Services Menu

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
  • Scientific program management
  • Sponsor representative
  • Financial program management
  • Governance and communication
  • Dissemination and valorization

Non-clinical

Involving our non-clinical experts early will de-risk your development activities and enable decision making at critical junctures giving you the competitive advantage you need to get you to the clinic.

  • Advice on non-clinical development strategy
  • Analysis of regulatory pathways
  • Design of in vitro and in vivo studies
  • CRO selection and contract negotiation
  • Interpretation of non-clinical data and writing preclinical study reports
  • Review of non-clinical data in conjunction with regulatory framework
  • Coordination of toxicology studies

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
  • CMC leadership
  • CDMO selection
  • Formulation development and stability testing
  • Analytical methods and characterization
  • 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
  • Target product profile development
  • Support scientific advice
  • Support health authority interaction
  • eCTD, reports, and submission documents

Quality

Our scalable solutions are offering high standards of compliance, privacy & security in all GxP disciplines.

  • Inspection readiness
  • Training and advicee.g. On ICH E6 GCP guidelines and GCP-related laws and regulations
  • Support and advice on the development of your GCP-based QMS
  • GDPR compliance
  • Auditing

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 operations plans and manualse.g. Project plans, Communication plans, Operational plans, Monitoring plans
  • Study feasibility and site selection
  • Clinical monitoring

Data Management

We transform data into knowledge, using state-of-the-art Electronic Data Capturing systems.

  • Development of data management plan
  • Development of data validation plan
  • eCRF design and setup
  • User acceptance testing of eCRF and validation checks
  • eCRF training for users
  • Continuous data review (including query management)
  • Integration of electronic data from central lab in the eCRF
  • Coding of medical terminologye.g. Adverse events, medical history, medications
  • Serious adverse event reconciliation between eCRF and safety database
  • Database lock and data exports
  • Development of statistical analysis plan
  • Development of randomization listings
  • Perform power calculation and provide statistical input on the protocol
  • Development, validation, and documentation of SAS programs
  • Development of specifications for analysis datasetse.g. Tables, listing, figures
  • CDISC/ADAM conversion
  • Generation of statistical reports

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 of statistical analysis plan
  • Development of randomization listings
  • Development, validation, and documentation of SAS programs
  • CDISC/ADAM conversion
  • Development of specifications for analysis datasetse.g. Tables, listing, figures
  • Generation of statistical reports

Safety Management & Medical Monitoring

We ensure safety is properly managed throughout the lifecycle of your programs.

  • Global drug safety project management
  • Expedited reporting to competent authorities, ethics committees, and investigator sites
  • Responsible person for Eudravigilance oversight
  • Eudravigilance setup and management
  • Electronic management of SAEs on the safety database
  • Reconciliation with clinical database
  • Six-monthly and quarterly reporting to competent authorities and ethics committees
  • Signal detection
  • Preparation and distribution of DSURs
  • Setup and management of DSMB
  • Medical oversight of clinical trials
  • Coding of medical terminology

Insourcing

We ensure you can take advantage of professionals with diverse backgrounds, expertise, and international contacts.

  • Trained life science professionals
  • Flexible staffing models
  • Flexible contract durations
  • Individuals or teams
  • Diverse backgrounds and expertise
  • Flexible staff locations

Regulatory Submissions

From design to approval of your clinical trial.

  • Translation of guidelines / regulatory requirements into clinical trial designs
  • Development, review, and approval of all essential clinical trial documents.
  • Submissions to competent authorities and IECs/IRBs
  • Submission of Periodic Updates and End of Trial Notifications

Medical & Scientific Writing

Our medical writers transform complex ideas into concise documents that prove to be essential to publish reliable research data.

  • Trial Synopsis
  • Clinical Study Protocol
  • Investigator's Brochure
  • Investigational Medicinal Product Dossier
  • Clinical Study Report
  • Scientific Publications