Expertise and innovation in every clinical protocol development

Ensure Feasibility, Security, and End-Point Focus with our Domain Experts

NStrategically designed to achieve critical outcomes
NTailored to align with real-world trial settings
NLed by seasoned professionals
NStreamlined processes and proven methodologies

Ensure Feasibility, Security, and End-Point Focus with our Domain Experts

NStrategically designed to achieve critical outcomes
NTailored to align with real-world trial settings
NLed by seasoned professionals
NStreamlined processes and proven methodologies

Discover scientific accuracy using our protocol development service

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.

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Main areas of Protocol development

Unleash the potential of our service offerings

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.

Study outcomes and endpoints

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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.

Data collection methods and timing

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Effective data collection starts with the right timing and approach. We guide you in structuring data collection steps, choosing cost-effective methods, and selecting participant questionnaires that fit study needs.

Statistical considerations

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A strong statistical plan ensures valid results. Our biostatisticians assist with protocol writing, analysis, and reporting while ensuring compliance with ICH, FDA, and EMA guidelines.

Safety data collection and reporting

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Accurate safety data is essential. We implement global safety reporting standards like ICH E19 to ensure proper documentation and compliance with regulatory requirements.

Study design

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A well-planned study design streamlines execution. We help structure participant workflows, define study arms, and optimize data collection to improve trial efficiency.

Sample size determination

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Determining the right sample size is crucial for valid results. Our experts calculate sample sizes based on study needs and conduct literature reviews to refine effect size estimates.

Adaptive clinical trials

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Adaptive designs allow trials to adjust based on interim results. Our team integrates adaptive approaches to save time, optimize outcomes, and improve trial flexibility.

Study outcomes and endpoints

:

;

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.

Data collection methods and timing

:

;

Effective data collection starts with the right timing and approach. We guide you in structuring data collection steps, choosing cost-effective methods, and selecting participant questionnaires that fit study needs.

Statistical considerations

:

;

A strong statistical plan ensures valid results. Our biostatisticians assist with protocol writing, analysis, and reporting while ensuring compliance with ICH, FDA, and EMA guidelines.

Safety data collection and reporting

:

;

Accurate safety data is essential. We implement global safety reporting standards like ICH E19 to ensure proper documentation and compliance with regulatory requirements.

Study design

:

;

A well-planned study design streamlines execution. We help structure participant workflows, define study arms, and optimize data collection to improve trial efficiency.

Sample size determination

:

;

Determining the right sample size is crucial for valid results. Our experts calculate sample sizes based on study needs and conduct literature reviews to refine effect size estimates.

Adaptive clinical trials

:

;

Adaptive designs allow trials to adjust based on interim results. Our team integrates adaptive approaches to save time, optimize outcomes, and improve trial flexibility.

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Benefits of our service

Elevate efficiency and accuracy in your research

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.

Expert guidance

Wemedoo brings precision in crafting study objectives and endpoints. Our experts will help you not only choose the best outcomes and endpoints but consult on the most effective designs.

Optimized data Collection

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

Regulatory compliance

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

Statistical considerations

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

Eager to explore tailored services?

Discover how our clinical trial services can revolutionize your research. Take the first step towards unmatched trial efficiency and success today.

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Frequently asked questions

Get the answers you need about our protocol development services

What is included in Wemedoo protocol development service?

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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?

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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?

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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?

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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?

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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 cinical trials.

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Explore related services

Discover comprehensive solutions for your clinical trial needs

Beyond protocol development, Wemedoo offers a comprehensive suite of integrated data operation 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.

Clinical Data Management

Risk-Based Monitoring and Source Data Review

eTMF Setup and Administration

Biostatistics and Statistical Programming

CDISC-Compliant Dataset Generation

Medical Writing and Documentation

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.

See what our clients say

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

"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 Appeltree 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

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.

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