Professional Services for Clinical Trials
Clinical trial design, protocol development and medical writing
Our team combines clinical, statistical, and regulatory expertise to deliver clinical study protocol writing, CSR writing services, informed consent form writing, lay summaries writing service, and other submission-ready documentation aligned with ICH GCP guidelines.
Protocol Development
Clinical trial protocol development services
A well-structured protocol is the backbone of every successful clinical trial. Our protocol development services ensure that every study is scientifically rigorous, operationally feasible, and fully aligned with the International Council for Harmonisation Good Clinical Practice (ICH GCP) and global regulatory expectations.
We specialize in clinical study protocol writing and protocol design for clinical trials, delivering documents that are submission-ready and optimized for execution.
Study design includes:
- Definition of study objectives, endpoints and hypotheses
- Study design and methodology
- Data collection methods and timing
- Sample size determination and statistical justification
Protocol writing includes:
- Writing of Protocol, Informed Consent Form (ICF), Electronic Case Report Form (eCRF), data management plan, Trial Master File (TMF) writing, and Clinical Study Report (CSR) writing
- Translating the approved study design into a full protocol document
- Structuring all required clinical, methodological, operational, and regulatory sections
- Ensuring regulatory and GCP compliance in all protocol sections
- Finalizing protocol versions ready for submission and trial start
By integrating statistical expertise and clinical insight, we create regulatory-ready clinical trial protocols that reduce delays and improve trial efficiency.
Core Capabilities
Medical writing for clinical trials
High-quality medical writing for clinical trials is essential to ensure that complex clinical data is clearly communicated and compliant with global regulatory standards.
Our regulatory writing services for clinical trials support full clinical development lifecycle: from early-phase planning to final submission and post-trial reporting.
Expert perspective
Writing that regulators trust
"Great writing is clear, concise, and captivating. Doubly so in clinical trials."
Data Strategy
Data strategy alignment in clinical trials
Effective clinical trial design requires alignment between clinical endpoints, statistical analysis, and data collection strategy.
Our multidisciplinary teams ensure:
This alignment is further supported by oomnia, Clinical Research Information System (CRIS), enabling consistent data flow from protocol design to reporting.
Our Approach
Our medical writing process
Our structured approach ensures scientific accuracy, regulatory compliance, and timely delivery of high-quality clinical documentation.
Study design includes:
- Definition of study objectives and hypotheses
- Study design and methodology (e.g., interventional, observational)
- Definition of outcomes and endpoints
- Data collection strategy and timepoints
- Sample size estimation and statistical considerations
- Feasibility assessment and risk evaluation
Protocol writing includes:
- Translating the approved study design into a comprehensive clinical protocol
- Structuring all required regulatory and operational sections
- Ensuring alignment with ICH GCP and applicable regulatory expectations
- Consistent terminology, formatting, and document standardization
- Preparation of a submission-ready protocol for ethics committees and trial startup
Regulatory Standards
Regulatory compliance and industry standards
We ensure compliance with the following regulatory frameworks and data standards:
ICH E6 (R3) Good Clinical Practice (GCP)
Full alignment with the latest ICH GCP guidelines governing clinical trial conduct and documentation
FDA 21 CFR Part 11 – Electronic Records and Signatures
Fully compatible with 21 CFR Part 11 electronic records and signature requirements
EMA Clinical Trial Regulation (EU CTR 536/2014)
Documentation structured in accordance with EU CTR standards and oversight principles
ISO 14155 – Clinical Investigation of Medical Devices
Compliant processes for medical device clinical investigations and regulatory submissions
CDISC Standards (SDTM, ADaM, CDASH)
Clinical data organized in accordance with CDISC SDTM, ADaM, and CDASH standards for regulatory submission
FDA Risk-Based Monitoring Guidance
Risk-proportionate oversight approaches applied throughout the study lifecycle in line with FDA guidance
Data integrity principles (ALCOA+)
All data and documentation meets ALCOA+ data integrity requirements throughout the trial lifecycle
All documentation is developed under controlled processes with version control, audit trails, and quality review procedures.
Trusted by research teams across the clinical ecosystem
From global pharma to academic research sites, our unified platform adapts to how your team works.
Client Testimonials
Collaboration built on trust and innovation
Wemedoo's technology, expertise, and intimate engagement with our team in the development of the EDC, site/patient interface, and metric capabilities are unique. They provided insight and challenged the underlying assumptions to ensure the study's goals and objectives were clearly defined and the operating structure matched with the study's intent. Their system is not a one-size-fits-all and they adapt to the needs of the sponsor, sites, physicians, and the study requirements into a system that merges health information/data and can then become not only informative but actionable.
James Kuras
Vice President of Clinical Affairs and Operations at Centinel Spine
Wemedoo's cross-functional, integrated teams capture EDC set-up, go-live, data capture, data cleaning, and finally data analysis in a globally compliant fashion supporting trials in different geographies including the US. Their speed of addressing customer needs sets in my personal experience industry benchmark whilst keeping these data solutions lean and affordable. Besides the great proprietary systems they use, their integrated team approach with personal responsibility and honest commitment to targeting outcomes differentiates the Wemedoo team from other providers. Wemedoo only made Oxular's key initial trial, a device-drug trial possible, as based on some pre-work, the Wemedoo team could substantially adapt and update the first EDC ideas for a trial under a US FDA IND. The Wemedoo team worked extremely focused on familiarizing US trial sites and clinical CROs with the use of their system, which turned out to be a key success factor of the respective trial. The highly professional and up-to-date capabilities in data sciences were mirrored by customer-centricity and super fast timelines of integrating mandatory adaptations to the data systems.
Friedrich Asmus
Former Chief Medical Officer at OXULAR
All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team.
Georg Mathis, PhD
CEO at Appletree CI Group AG
Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail.
Martina Diminic Smetisko, DMD
Managing Director at Marti Farm Ltd
Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together.
Volodymyr Stus, MD
Biopharmaceutics and Clinical Research Department Manager at Polpharma SA
Complex adaptive trials demand speed, precision, and system stability. With oomnia, Wemedoo's unified clinical trial software maintained continuous drug supply oversight, real-time data capture above 99%, and zero Randomization and Trial Supply Management (RTSM) dispensing errors throughout the study. The study reached database lock within 3 days after Last Patient Last Visit (LPLV), a direct result of integrated EDC–RTSM execution and proactive technical support. Wemedoo's technology and team responsiveness played a key role in meeting aggressive milestones.
Dhiraj Patel, Dr.
Director at Velocious Clinical Research
Our Expertise
Proven expertise
Wemedoo delivers high-quality clinical trial documentation through a combination of scientific expertise, cross-functional collaboration, and a structured approach to clinical data interpretation.
Our teams work closely across biostatistics and clinical functions to ensure that every document is accurate, consistent, and aligned with study objectives.
Talk to our expertsGet in Touch
Looking for medical writing support for your clinical trial?
Whether you need protocol development, regulatory documentation, or clinical study reports, our team is ready to support your study from design to submission.
Contact usResources
Trial design & medical writing resources
Trial Design & Medical Writing
Wemedoo returns to Xraised episode 2 with unified data in focus
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