🇨🇭 Swiss Data Privacy & Precision

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.

ISO 27001 SOC 2 FDA 21 CFR Part 11 GDPR & HIPAA

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.

Protocol

Clinical study protocol writing

We provide expert clinical study protocol writing services for Phase I–IV trials, ensuring full scientific accuracy and regulatory compliance.

Our services include:

  • Protocol authoring and development
  • Protocol amendments and updates
  • Alignment with ICH GCP and regulatory guidelines
  • Integration with statistical and data management plans
Discuss your study requirements

Regulatory

Regulatory submission documents

Our team delivers high-quality regulatory writing services for clinical trial submissions, ensuring acceptance by regulatory authorities.

We prepare:

  • Investigator's Brochure (IB)
  • Investigational New Drug (IND) applications
  • Clinical Trial Application (CTA)
  • Safety data collection and reporting documentation
  • Clinical trial submission packages

Patient Documents

Patient-facing documents

All documentation is structured to meet the expectations of U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and global regulatory authorities.

  • Informed Consent Form (ICF)
  • Pregnant participant informed consent
  • Lay protocol summaries
  • Lay summaries of clinical study results
Get regulatory submission support

CSR

Clinical study report writing

We provide expert Clinical Study Report writing (CSR writing services) that advance clinical data into structured, regulatory-compliant reports.

Our services include:

  • CSR writing according to International Council for Harmonisation (ICH) E3 – Structure and Content of Clinical Study Reports Guidelines
  • Data interpretation and scientific narrative development
  • Regulatory formatting and compliance checks
  • Integration of statistical results and study outcomes

Our reports ensure that regulators, reviewers, and stakeholders clearly understand study outcomes and scientific conclusions.

Expert perspective

Writing that regulators trust

"Great writing is clear, concise, and captivating. Doubly so in clinical trials."
Aleksa Jovanovic
Clinical data and scientific content specialist

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:

Clearly defined clinical endpoints Statistical analysis plans Efficient and compliant data collection methods Full alignment between protocol, and reporting documentation

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.

Who we serve

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

Centinel Spine logo
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

Oxular logo
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

Appletree CI Group AG logo
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

Marti Farm Ltd logo
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

Polpharma SA logo
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

Velocious Clinical Research logo
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 experts
Clear and structured clinical documentation
Scientifically rigorous protocol development
Consistent and reliable clinical study reports
Accurate interpretation of clinical and statistical data
Efficient and timely document delivery

Get 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 us

Resources

Trial design & medical writing resources

Trial Design & Medical Writing

Blog

Wemedoo returns to Xraised episode 2 with unified data in focus

July 9, 2026

Blog

Artificial Intelligence in Clinical Trials: Balancing Innovation and Accuracy

June 24, 2026

Blog

A new scientific publication featuring Wemedoo researchers has been published in BMC Medical Research Methodology

June 24, 2026

Blog

The CRO’s Guide to Winning Sponsor Trust

June 24, 2026

Blog

Key Takeaways from EUCROF25: AI, Integration, and CRO Challenges in Clinical Trials

June 24, 2026

Blog

Wemedoo Becomes an Associate Member of EUCROF

June 24, 2026

Blog

Across Global Alliance Selects oomnia as a Central Trial Infrastructure

June 24, 2026

Blog

Revolutionizing Clinical Trials: How Wemedoo is Accelerating Global Research

June 24, 2026

Blog

Why does unified data matter? Hear from Wemedoo at Swiss Biotech Day!

June 24, 2026

Blog

Wemedoo in The CEO Magazine: Fixing Clinical Trials

June 24, 2026

Blog

Wemedoo in Forbes: From Clinical Frustration to Real Innovation

June 24, 2026

Blog

New Era of Clinical Trials with oomnia®: Built for Complexity, Designed for Simplicity

June 24, 2026

Blog

Dr. Nikola Cihoric elected to EUCROF AI Expert Group

June 24, 2026

Blog

Wemedoo announces strategic partnership with mediri to streamline imaging data management in clinical trials

June 24, 2026

Blog

Wemedoo’s innovation journey with oomnia on Xraised

June 24, 2026

Blog

The hidden cost of disconnected systems in biotech and the path to streamlined trials

June 24, 2026

Blog

Wemedoo receives SCDM innovator start-up of the year 2025 award

June 24, 2026

Blog

Wemedoo featured on BioSpace

June 24, 2026

Blog

Wemedoo joins Xraised again to share new perspectives

June 24, 2026

Blog

Wemedoo featured on AP News

June 24, 2026

Blog

Clinical trial trends in 2025

June 24, 2026

Blog

Why eClinical architectures have reached their limits, and a new category is emerging

June 24, 2026

Blog

Why compliance risk increases in modular eClinical setups

June 24, 2026

Blog

What makes a clinical trial software truly unified

June 24, 2026

Blog

Top EDC software solutions for clinical trial teams

June 24, 2026

Frequently Asked Questions

What are medical writing services for clinical trials?

Medical writing services for clinical trials involve the preparation of regulatory, scientific, and clinical documents required throughout the trial lifecycle. Wemedoo provides medical writing services including clinical study reports (CSRs), protocols, investigator brochures, informed consent forms, and regulatory submission documents.

What types of documents does Wemedoo medical writing cover?

Wemedoo medical writing services cover clinical study reports (CSRs), clinical study protocols, investigator brochures (IBs), informed consent documents, clinical overviews and summaries, lay summaries, safety reports, annual reports, and other regulatory documents required by FDA, EMA, and other authorities.

How does Wemedoo ensure regulatory compliance in medical writing?

Wemedoo ensures regulatory compliance through writers experienced in ICH E6 (R3), ICH E3, ICH M4, and CTD format requirements, internal quality review processes, regulatory template libraries, and close collaboration with biostatistics teams to ensure accurate representation of study results.

Can Wemedoo handle medical writing for rare therapeutic areas?

Yes, Wemedoo medical writing team has experience across multiple therapeutic areas including oncology, cardiology, neurology, immunology, dermatology, ophthalmology, and rare diseases. The team leverages therapeutic area expertise and literature research to produce scientifically accurate documents.

What is the benefit of outsourcing medical writing?

Outsourcing medical writing to Wemedoo provides access to experienced writers, faster document turnaround, consistent quality, regulatory expertise, and cost savings compared to maintaining an in-house medical writing team. It also provides surge capacity for peak submission periods.