Our services

We offer the full
range of clinical trial 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

Clinical Trial Management

From trial synopsis development up to finalization of the clinical report, we are here for you every step of the way.

  • Global project management
  • Clinical development plan
  • Development of trial synopsis, protocol, and study report
  • Study feasibility and site selection
  • Clinical operations plans and manualse.g. Project plans, Communication plans, Operational plans, Monitoring plans
  • Clinical monitoring

Regulatory Strategy & Affairs

From proof of concept to marketing authorization.

  • Target product profile development
  • Development, reviewing, and approving all clinical documentation required to start a clinical trial
  • Preparation of regulatory scientific consultations
  • Perform regulatory submissions at the competent authority / ethics committees
  • Collection and check for completeness of regulatory and EC documents
  • Obtaining approval for clinical trial in each of the participating centers

Grant Proposal Development

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
  • Financial program management

Data Management & Biostatistics

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

  • Development of data management plan
  • eCRF design and setup
  • Development of data validation plan
  • User acceptance testing of eCRF and validation checks
  • eCRF training for users
  • Integration of electronic data from central lab in the eCRF
  • Continuous data review (including query management)
  • 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

Pharmacovigilance & Medical Monitoring

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

  • Global drug safety project management
  • Eudravigilance setup and management
  • Collection and follow-up of serious adverse events (SAEs) from clinical trials
  • Electronic management of SAEs on the safety database
  • Expedited reporting to competent authorities
  • Expedited reporting to ethics committees and investigator sites
  • Six-monthly and quarterly reporting to competent authorities and ethics committees
  • Responsible person for Eudravigilance oversight
  • Reconciliation with clinical database
  • Compliance review and oversight
  • Signal detection
  • Preparation and distribution of DSURs
  • Medical oversight of clinical trials
  • Setup of DSMB
  • Management of DSMB
  • 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 contract durations
  • Flexible staffing models
  • Flexible staff locations
  • Diverse backgrounds and expertise

Quality Management & Auditing

We always deliver high quality services to ensure operational excellence.

  • Quality Management System (QMS)Designed to meet the requirements of the international standard ICH E6 (R2) Guideline of Good Clinical Practice (GCP), based on the principles of ISO 9001:2015
  • Training and advicee.g. On ICH E6 GCP guidelines and GCP-related laws and regulations
  • Quality review of all clinical documentation required to start a clinical trial
  • Support and advice on the development of your GCP-based QMS
  • Vendor assessment
  • GDPR compliance
  • Audits of Investigators / Sites
  • Audits of Vendors (GCP, GLP and GMP)
  • Internal system audits