Clinical trials
Statandocs is a full-service contract research organisation. We can manage a complete trial or work alongside the client and other providers.
Programme and documentation
We justify the clinical programme, study sequence and relationships between studies. Medical writers, medical experts and monitors, biostatisticians, data managers and clinical specialists work together.
- Concept or synopsis, protocol and applicable study documents.
- Investigator brochures, informed consent materials, questionnaires, scales and diaries.
- Development and validation of PRO instruments, including electronic tools for computers and mobile devices.
- Feasibility assessment with selected centres.
Study organisation and conduct
We prepare submissions and support approvals, contracts and site supplies.
- Interaction with competent authorities and ethics committees.
- Laboratories, imaging centres and other providers.
- Document workflows, material supplies and applicable import/export authorisations.
- Site selection, initiation, monitoring and close-out visits, co-monitoring and audits.
Medical and central monitoring
Clinical, medical, data management and biostatistics specialists work as one study team.
- Central monitoring and data review.
- Independent data monitoring committee support, including specialists, independent analysis and documentation.
- Preparation and submission of amendments.
Data, analysis and close-out
We support database management and lock, statistical analysis and final reporting. Outputs can also include dossier materials, publications and information for healthcare professionals and patients.
How we can support you
An individual document, study, project stage or complete programme. We agree source data, deliverables, timelines and responsibilities before work begins.
Where do we start?
Tell us about your product and objective. We will assess the available information, identify what is needed and agree the right scope of work.