Strategic partner throughout the development process

We offer strategic support through the entire process of developing pharmaceuticals and medical devices to ensure that the right methdology and quality standards are maintained throughout the project, from study desin, protocol development and statistical analysis plan (SAP), to reporting and presentation of results. We regularly collaborate with CROs and have experience working with guidelines from regulatory agencies such as the FDA and EMA.

We offer

• Study design and development of protocols and statistical analysis plans (SAPs)

• Consulting tailored to guidelines from regulatory agencies such as the FDA and EMA

• Point of contact and collaboration partner with CROs

• Reporting and interpretation of results from both phase I-IV clinical trials and Real World Evdence studies

• Liaison with regulatory authorities regarding, for example, data requests and approvals for drugs or medical devices

Who is this for

This service is aimed at phamaceutical and biotech companies, government agencies, and CROs that require statistical expertise in all phases of development.