At Elementrial, we support all essential elements of clinical trials — from early design through execution to final dissemination. Our services are modular and flexible: you select only the components you need. Whether working independently or alongside your internal or academic teams, we deliver focused, senior-level support with no overhead and no delegation.
Core Elements of Support
Study Design & Planning
- Scientific consulting and protocol development
- Feasibility, risk assessment, and realistic budgeting
- Submission-ready study and statistical plans
Regulatory Submissions
- Preparation of submission packages for ethics committees and competent authorities
- Guidance on clinical trial application (CTA) documentation
- Regulatory strategy for medical devices and medicinal products
Operational Setup & Oversight
- Site selection, startup, and vendor coordination
- Monitoring strategy and recruitment support
- eCRF and eTMF solution selection tailored to your team and project scale
Data Management
- eCRF setup and database validation coordination
- Data cleaning and query handling strategies
- Support for database lock and statistical data handover
Medical Writing
- Authoring of core study documents: protocols, investigator brochures, ICFs
- Final study reports and regulatory submission documentation
- Scientific publications in peer-reviewed journals and conference posters
- Plain language summaries for patients and the public
- Registration and updates in clinical trial registries (e.g., ClinicalTrials.gov)
Modular by Design
Each service element can stand alone or be part of a coordinated support package. You maintain full control and transparency — while we ensure that each component is handled with expertise, clarity, and precision.
We offer a free 30-minute consultation to explore your study idea, challenge, or need.
Email us at office@elementrial.com
Let us know a bit about your project or simply write “Interested in a call” — we’ll take it from there.