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
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

Discover scientific accuracy using our protocol development service

Our specialists support you with clinical protocol development, a crucial aspect of conducting successful clinical trials. We understand the nuances which provide a solid foundation for your research, ensuring rigorous design, clear objectives, and compliance with regulatory standards. Our solutions emphasize a collaborative approach.

Explore how our service tailors protocols to meet your unique needs of each study while maintaining the highest standards of scientific integrity and operational efficiency.

Main areas of Protocol development

Unleash the potential of our service offerings

The essential elements of the Wemedoo protocol development service include for example drafting a protocol from scratch, consulting on protocol design or the choice of outcomes and endpoints, data management and biostatistical review, or sample size calculations. Our team is comprised of MDs, PhDs, and MD/PhDs, with many years of experience in various indications and knowledge of regulatory guidelines. We deliver a unique user experience while guaranteeing that your protocol meets all applicable ICH guidelines and submission requirements.

Study outcomes and endpoints

:
;

Our biostatistical and data management experts have many years of experience when it comes to helping sponsors choose the best primary and secondary endpoint for their study. From simple protocol designs to gate-keeping methods, it is our desire to ensure that the outcomes and endpoints are clearly defined, maximizing your chances of success.

Data collection methods and timing

:
;

Our experts will help you to define how, in what sequence, and when data will be collected. We can also help you choose questionnaires which best suit your needs and budget, and consult in the best method and timing for delivering them to participants.

Statistical considerations

:
;

A well written statistical section of the protocol can be imperative to your trial's success. Our team is purpose-built to support you through every stage, from protocol writing to statistical analysis and reporting. Providing consultation and writing the statistical section of your protocol ensures that it defines statistical processes to meet specified outcomes and endpoints effectively. Additionally, it ensures that your trial meets ICH E9, EMEA, and FDA guidelines.

Safety data collection and reporting

:
;

The incorporation of regulatory compliant plans for safety data collection and reporting are critical to any protocol. Our experts will work with you to ensure that the protocol meets all ICH E19 safety guidelines.

Study design

:
;

Study design is a frequently misunderstood cornerstone of a trial protocol, which goes beyond defining the study type (randomized, observational, etc.) and the study arms. Our experts collaborate with you to design the participant journey, ensuring that the timing and methods of data collection accurately reflect each participant's CRF.

Sample size determination

:
;

Our expert biostatisticians can perform sample size calculations for your study. Additionally, if you are unsure of the effect size to be used for the sample size calculations, we offer systematic literature reviews to inform and guide your decision-making process.

Adaptive clinical trials

:
;

Adaptive clinical trials are getting increasingly prevalent. With years of experience, our team specializes in designing and writing the statistical sections of trial protocols, incorporating adaptive trial designs. Even if you are not thinking about adaptive design, it may save time and money in the long run.

Study outcomes and endpoints

:
;
Our biostatistical and data management experts have many years of experience when it comes to helping sponsors choose the best primary and secondary endpoint for their study. From simple protocol designs to gate-keeping methods, it is our desire to ensure that the outcomes and endpoints are clearly defined, maximizing your chances of success.

Data collection methods and timing

:
;
Our experts will help you to define how, in what sequence, and when data will be collected. We can also help you choose questionnaires which best suit your needs and budget, and consult in the best method and timing for delivering them to participants.

Statistical considerations

:
;
A well written statistical section of the protocol can be imperative to your trial's success. Our team is purpose-built to support you through every stage, from protocol writing to statistical analysis and reporting. Providing consultation and writing the statistical section of your protocol ensures that it defines statistical processes to meet specified outcomes and endpoints effectively. Additionally, it ensures that your trial meets ICH E9, EMEA, and FDA guidelines.

Safety data collection and reporting

:
;
The incorporation of regulatory compliant plans for safety data collection and reporting are critical to any protocol. Our experts will work with you to ensure that the protocol meets all ICH E19 safety guidelines.

Study design

:
;

Study design is a frequently misunderstood cornerstone of a trial protocol, which goes beyond defining the study type (randomized, observational, etc.) and the study arms. Our experts collaborate with you to design the participant journey, ensuring that the timing and methods of data collection accurately reflect each participant's CRF.

Sample size determination

:
;
Our expert biostatisticians can perform sample size calculations for your study. Additionally, if you are unsure of the effect size to be used for the sample size calculations, we offer systematic literature reviews to inform and guide your decision-making process.

Adaptive clinical trials

:
;
Adaptive clinical trials are getting increasingly prevalent. With years of experience, our team specializes in designing and writing the statistical sections of trial protocols, incorporating adaptive trial designs. Even if you are not thinking about adaptive design, it may save time and money in the long run.

trusted by

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.

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.

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.

CURIOUS?

Learn more about how we can support your cinical trials.

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 – Surpassing Industry Standards
Our unified clinical trial software is designed with compliance at its forefront, 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.

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, RTSM, eTMF, ePRO, eCOA, and CTMS. In combination with our professional services we can provide end-to-end support to transform your clinical research.