Clinical trial professional services, from protocol to submission
AIClinTrack combines trial design and medical writing, clinical data management, and biostatistics and statistical programming — helping sponsors and CROs design, run, and report studies with clarity, consistency, and control.
Three disciplines, one accountable team
Engage a single service or combine them so documents, data, and analyses stay aligned throughout the study. Scope, systems, standards, and responsibilities are agreed before work begins.
Trial Design & Medical Writing
Clear, consistent study documents from first concept to submission.
View detailsClinical Data Management
Traceable, clean data from CRF design to database lock.
View detailsBiostatistics & Statistical Programming
Sound methods and CDISC-conformant, submission-ready outputs.
View detailsStudy design, protocol development and medical writing
Our writers work with your clinical, statistical, and regulatory leads to shape the study design and turn it into well-structured, review-ready documents — keeping terminology, endpoints, and statistical intent consistent from the protocol through to the clinical study report.
- Protocol
- ICF
- IB
- CSR
- Lay summary
- Submission documents
What we deliver
- Study design input: objectives, endpoints, population and schedule of assessments
- Protocol development, amendments and synopsis drafting
- Informed consent forms and participant-facing materials
- Investigator's brochures and study-specific plans
- Clinical study reports structured to ICH E3 expectations
- Plain-language (lay) summaries and regulatory submission documents
Clinical data management services
System-agnostic data management that runs in your EDC or a platform agreed for the study. Structured processes, ongoing validation, and risk-based review keep data quality visible throughout conduct — not only at close-out — so database lock arrives on schedule with inspection-ready documentation.
- DMP
- eCRF specs
- Edit checks
- UAT
- Coding
- Database lock
What we deliver
- Data management plans and CRF / eCRF design
- Database specifications, edit checks and user acceptance testing
- Ongoing data review, query management and listings
- Medical coding and external / safety data reconciliation
- Data quality metrics and risk-based review
- Database-lock readiness and controlled archive handoff
Biostatistics and statistical programming
Statisticians and programmers support the study from design through reporting — contributing to sample size and analysis strategy, then producing documented, quality-controlled datasets and outputs that are prepared for sponsor review and regulatory submission.
- SAP
- SDTM
- ADaM
- define.xml
- TLFs
- Interim analyses
What we deliver
- Statistical input to study design and sample-size calculation
- Statistical analysis plans and randomization specifications
- CDISC SDTM and ADaM datasets with define.xml
- Tables, listings and figures (TLFs) with independent QC
- Interim and data monitoring committee analyses
- Statistical sections for CSRs and submission support
From scope to submission-ready outputs
A shared plan keeps writing, data, and statistics aligned while preserving sponsor oversight and authorized decision-making.
- 1
Scope the need
Review the protocol or concept, timelines, systems, and standards, then agree which disciplines, deliverables, and responsibilities are in scope.
- 2
Plan as one team
Writers, data managers, and statisticians align on a shared plan so endpoints, data structures, and analyses stay consistent from day one.
- 3
Deliver with visible quality
Work progresses through documented review and QC steps, with clear ownership, status reporting, and escalation paths for your team.
- 4
Hand off submission-ready outputs
Final documents, locked data, and analysis outputs are delivered with supporting documentation and an agreed archive handoff.
Support across study types, therapeutic areas and organizations
Clinical trial types
From early-phase studies to complex multi-site programs.
- Phase I–IV interventional
- Observational & registry
- Multi-site & multi-country
- Investigator-initiated
Therapeutic areas
Fit and specialist needs are confirmed during study assessment.
- Oncology
- Neurology
- Cardiology
- Infectious diseases
- Endocrinology & metabolism
- Respiratory
Who we work with
Organizations with different structures and operating models.
- Pharma & biotech sponsors
- Contract research organizations
- Academic & research institutions
- Medical device companies
Works with your systems — or alongside ours
Our teams can work inside your existing EDC, statistical environment, and SOPs, or pair professional services with AIClinTrack CTMS and the eTMF foundation for shared visibility of milestones, documents, and ownership.
Claims and responsibilities are scope-specific
Applicable regulations, standards, validated methods, software, qualified personnel, and partner responsibilities are confirmed before work begins. Final clinical, statistical, and regulatory decisions remain with the authorized sponsor and responsible parties.
Questions about our professional services
Ready to strengthen your clinical trial delivery?
Share your protocol stage, timelines, and the support you need — writing, data, statistics, or all three — and we will propose a clear scope.