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Logo Protocol Development

We offer expertise & innovation in every clinical protocol development, and ensure feasibility, security, and endpoint focus with our domain experts.

Strategically designed to achieve critical outcomes
Tailored to align with real-world trial settings
Led by seasoned professional
Streamlined processes & proven methodologies

Discover Scientific Accuracy

Crafting a clinical trial protocol is more than just a checklist – it’s the foundation of trial success. At Wemedoo, we go beyond standard protocol development by ensuring precision, regulatory compliance, and streamlined execution at every stage. Our team of MDs, PhDs, and biostatisticians brings deep expertise across therapeutic areas, ensuring that protocols are designed with scientific rigor while meeting all ICH guidelines and submission standards.

Explore how our service tailors protocols to meet your unique needs of each study.

Main Areas of Protocol Development

We support trials from initial concept to final submission, offering tailored protocol design, outcome and endpoint selection, and thorough biostatistical review. Every protocol is developed with a data-driven approach, incorporating sample size calculations and statistical validation to optimize study design. By combining strategic consulting with hands-on execution, we create protocols that not only meet regulatory requirements but also enhance trial efficiency and data integrity.

Defining clear study outcomes is key to trial success. Our experts help select primary and secondary endpoints that align with study goals and regulatory expectations, ensuring clarity and accuracy.

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Established Trust

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Benefits of Our Service

Our protocol development service brings a multitude of benefits to your clinical trial process. This service streamlines and accelerates the protocol development phase. Moreover, it also ensures rigorous scientific accuracy, regulatory compliance, successful submissions, and seamless trial conduct for clinical data managers, study coordinators, biostatisticians, and most of all participants.

Elevate Efficiency & Accuracy in Your Research

Expert Guidance

Wemedoo brings precision in crafting study objectives & endpoints. Our experts will help you choose the best outcomes & endpoints but the consult on the most effective design.

Optimized Data Collection

We are carefully delineating the methods, sequence, timing of data collection, and the participant journey. This aspect is frequently overlooked as essentials to trial success.

Regulatory Compliance

Wemedoo ensures that your trial protocol meets all ICH, EMA and FDA guidelines. We guarantee regulatory & ethical compliance & that your protocol submission goes smoothly.

Statistical Considerations

Our expertly written statistical protocols ensure regulatory compliance, but also give the best chance of successfully meeting all the correct study endpoints.

Looking for Clinical Trial Support That Fits Your Study?

Explore how our flexible, integrated services can help you accelerate timelines, improve quality, and reduce complexity.

Frequently Asked Questions

Get the answers you need about our protocol development services

What is included in Wemedoo protocol development service?

Our service covers the definition of study objectives and endpoints, study design, determination of data collection methodology and timing, sample size determination, writing or consulting on the statistical considerations, and implementing adaptive trial design. Apart from that, our protocol development service ensures compliance with regulatory standards, and quality assurance measures.

How does Wemedoo ensure regulatory compliance in protocol development?

Our team excels in all aspects of protocol design and development, including familiarity with relevant FDA, EMA, and ICH guidelines, as well as best practices and recommendations found in reputable industry and academic publications. We integrate the latest compliance requirements into every protocol we develop.

Can Wemedoo protocol development service be tailored to specific trial needs?

Absolutely! Protocol development in general cannot be organized into a one-size-fits-all approach. We work with you to tailor this service to the unique requirements and challenges of your individual clinical trial. Contact us so we can discuss your specific needs.

What are the time-saving benefits of using Wemedoo protocol development service?

While we streamline the protocol creation process, significant time and cost savings are realized when the protocol aligns outcomes and endpoints with the schedule of assessments. Additionally, aligning the schedule of assessments with data collection instruments further enhances efficiency. Moreover, ensuring alignment with statistical considerations optimizes the overall process. This especially reduces time and costs from conception, initiation, conduct, close out, and final reporting.

How does Wemedoo protocol development service contribute to participant safety?

Participant safety goes well beyond collecting adverse events and SAE reporting in a regulatory compliant manner. The careful definition of endpoints, study design, schedule of activities, sample size, and statistical considerations all contribute to participant safety. The most unsafe situation for participants is to be exposed to experimental treatments when the study has no chance of success due to poor design or poorly calculated sample size.

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Learn more about how we can support your clinical trials.

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Explore Related Services

Beyond protocol development, Wemedoo offers a comprehensive suite of integrated data operations services for clinical trials. At each step, we ensure your trial meets the highest quality and regulatory standards, while streamlining your clinical trial processes and saving you time and money. Discover our other services, all focusing on innovation and excellence in clinical research.

oomnia - Meeting Industry Standards

Our unified clinical trial software is designed with compliance at its core, meeting critical industry standards. Our commitment to these regulations ensures that your clinical trials are not only efficient but also adhere to the highest levels of data integrity, privacy, and ethical conduct.

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21 CFR
PART11

compliant

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HIPAA

compliant

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GDPR

compliant

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ICH GCP

compliant

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SWISS DATA PRIVACY LAW

compliant

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FAIR ALCOA+

compliant

See What Our Clients Say

Read more about the experiences from those who have partnered with us

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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 Appletree CI Group AG

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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

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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

Considering Unified Clinical Trial Software?

Experience oomnia, our all-in-one clinical trial software which unifies tools, such as EDC, eSource, RTSM, eTMF, ePRO, eCOA, eConsent, and CTMS. In combination with our professional services, we can provide end-to-end support to transform your clinical research.