Clinical research support from start-up to database lock.
Trial management, monitoring, data management, biostatistics and audit support for sponsors and research teams.
Stark Associates supports pharmaceutical, biotechnology, medical device and consumer healthcare sponsors across the phases of clinical development. Some clients need a complete functional team for a study; others need targeted help with one part of the work, such as monitoring capacity, data cleaning or statistical analysis. We scope each engagement around what you actually need.
Trial management and monitoring
Our clinical teams can support study start-up, site selection and activation, ongoing monitoring visits, and close-out. Clinical project managers coordinate vendors, timelines and budgets and keep sponsors informed with regular status reporting. Monitoring is performed under ICH GCP and the sponsor's or our procedures, as agreed.
Clinical data management
Data management support covers case report form design input, database build and user acceptance testing, data validation and query management, medical coding coordination and database lock activities. The goal is clean, traceable data that is ready for analysis on time.
Biostatistics and programming
Statisticians and programmers can contribute to protocol and statistical analysis plan development, sample-size considerations, analysis datasets, tables, listings and figures, and interpretation for clinical study reports.
Clinical quality and audits
Independent audits of investigator sites, vendors and trial master files help sponsors find and fix issues before an inspection does. Audit reports set out findings clearly and support corrective action planning.
How engagements work
Every engagement starts with a written scope, named team members and an agreed reporting rhythm. Work can run under your SOPs or ours, and can scale up or down as the study changes.
When sponsors call us
Common triggers are a monitoring backlog after slow enrollment, a study that needs a project manager mid-stream, or a data cleaning push before an interim analysis.
In each case we agree the scope first, then assign people who know the therapeutic area and the systems you use.
Clinical services at a glance
- Clinical trial management
- Protocol development
- Clinical trial monitoring
- Compliance and audit
- Clinical project management
- Clinical data management
Therapeutic experience
Our clinical teams have supported programs from early development through late-phase studies across cardiovascular, metabolic, neurology, nephrology, psychiatry, infectious diseases, hematology and oncology.