Services

 

Clinical Monitoring

For Austria and cross border

Study file preparation

Source data verification

Site management

Audit preparation

Project Management

International

Study planning

Provider selection and contract preparation

Provider management

Site selection

Pharmaceuticals, Biosimilars and Medical Devices

Study document preparation / review

Developing timelines and time tracking

Budgeting and fincancial control

Study drug management (logistics, blinding, randomization)

Study sample management / Lab management

Progress / status reports

Organizing Investigator Meedings, CRA Trainings, etc

Giving training sessions

Other study assessments (EGCs, x-rays, …)

Consulting

Study costs

Clinical team training (training on the job)

SOP and development of forms / templates

Strategic decisions (country selection, provider selection,...)

Timelines

Sharing country specific experience for submission processes