Clinical development partner

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.

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.

Chemistry, Manufacturing and Controls (CMC)

Our CMC experts support you in defining a CMC strategy resulting in a robust manufacturing process.

Regulatory

Our team of former regulators offer early development strategies from proof of concept to marketing application (MAA or NDA).

Strategic R&D planning

Our experts support you in navigating the complex journey from benchtop research to successful commercialisation.

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.

Quality

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

e.g. On ICH E6 GCP guidelines and GCP-related laws and regulations

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.

e.g. Project plans, Communication plans, Operational plans, Monitoring plans

Data Management

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

e.g. Adverse events, medical history, medications

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.

e.g. Tables, listing, figures

Safety Management & Medical Monitoring

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

Insourcing

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

Regulatory Submissions

From design to approval of your clinical trial.

Medical & Scientific Writing

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