REGULATORY COMPLIANCE WITH MEDICAL WRITING EXPERTISE

Unlock the Power of Clear and Concise Trial Documentation

NClear and concise communication of complex information
NTime and resource efficiency
NRegulatory compliance assurance
NEnhanced credibility towards stakeholders

Ensure regulatory compliance with our Medical writing expertise

Unlocking the Power of Clear and Concise Trial Documenation

NClear and concise communication of complex information
NTime and resource efficiency
NRegulatory compliance assurance
NEnhanced credibility towards stakeholders

Save valuable time and keep on track with our medical writing expertise

The medical writing and documentation services provided by Wemedoo are a critical component for the successful execution of your clinical trial. Our team of expert medical writers create clear, comprehensive, and regulatory-compliant documentation essential for all phases of your clinical research. From clinical study protocols and study reports to scientific publications, our service ensures your clinical trial documentation is meticulously crafted and aligned with the highest industry standards.

Discover how we can streamline your clinical trial process, effectively communicate complex information, and enhance the overall quality of your research documentation.

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Main areas of medical writing and documentation

Unlock the potential of our service offerings

Medical writing and documentation in clinical trials involves the professional writing of scientific documents related to the planning, conduction, and reporting of clinical research. Our medical writers support you in communicating complex medical information to various audiences, including regulatory authorities, healthcare professionals, and sometimes the public. Explore the main areas wherein Wemedoo can support you with our medical writing and documentation expertise, whether you are a clinical data manager, trial director, study coordinator, or in another position.

Preparation of study protocols

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The preparation of a clinical trial protocol is a complex task undertaken by a multidisciplinary team of experts. With years of experience and a deep understanding of clinical research, our PhD-level experts closely work with you to prepare a detailed and regulatory compliant study protocol.

Publications and manuscripts

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Our team of PhD-level researchers can assist in preparing or fully writing your manuscripts for scientific or medical journals. This helps to make the results of the research available to both the scientific community and the public. Collectively, our team has published hundreds of papers in leading peer-reviewed medical and scientific journals.

Communication materials

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Our PhD-level researchers have decades of experience in creating presentations, posters, and other documentation to present study results for medical conferences or campaigns. We are experts in data visualisation, and make sure that your results are presented clearly, succinctly, and understandably.

Clinical trial documentation and planning

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Each step in the setup, conduct, and finalization of a clinical trial requires appropriate regulatory documentation and plans. Some are completely written by our team, while for others we collaborate with corresponding stakeholders. All our services include the appropriate documentation. Some examples include eCRF validation reports, data validation plans, TMF plans, medical coding plans, and many more.

Interim and final statistical analysis reports

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At Wemedoo, we craft each statistical analysis report, whether interim or final, as a stand-alone document, meticulously presenting the results of the statistical analysis of your clinical trial data.

Clinical study reports

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Upon completion of the study, our medical writers prepare comprehensive clinical study reports outlining the results, discussions, and conclusions of the study, which meet and exceed ICH E3 guidelines. Our team also follows industry standards such as transcelerate initiatives for developing common content.

Editing and quality assurance

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Medical writing also involves the review and editing of scientific documents to ensure accuracy, clarity and compliance with relevant guidelines and standards. If you need an external dispassionate review of your documentation, you can count on us to get the most out of it.

Interdisciplinary collaboration

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Our medical writers work closely with researchers, statisticians, regulatory experts and other professionals to ensure that documents are scientifically accurate and appropriate for the intended audience.

Preparation of study protocols

:

;

The preparation of a clinical trial protocol is a complex task undertaken by a multidisciplinary team of experts. With years of experience and a deep understanding of clinical research, our PhD-level experts closely work with you to prepare a detailed and regulatory compliant study protocol.

Publications and manuscripts

:

;

Our team of PhD-level researchers can assist in preparing or fully writing your manuscripts for scientific or medical journals. This helps to make the results of the research available to both the scientific community and the public. Collectively, our team has published hundreds of papers in leading peer-reviewed medical and scientific journals.

Communication materials

:

;

Our PhD-level researchers have decades of experience in creating presentations, posters, and other documentation to present study results for medical conferences or campaigns. We are experts in data visualisation, and make sure that your results are presented clearly, succinctly, and understandably.

Clinical trial documentation and planning

:

;

Each step in the setup, conduct, and finalization of a clinical trial requires appropriate regulatory documentation and plans. Some are completely written by our team, while for others we collaborate with corresponding stakeholders. All our services include the appropriate documentation. Some examples include eCRF validation reports, data validation plans, TMF plans, medical coding plans, and many more.

Interim and final statistical analysis reports

:

;

At Wemedoo, we craft each statistical analysis report, whether interim or final, as a stand-alone document, meticulously presenting the results of the statistical analysis of your clinical trial data.

Clinical study reports

:

;

Upon completion of the study, our medical writers prepare comprehensive clinical study reports outlining the results, discussions, and conclusions of the study, which meet and exceed ICH E3 guidelines. Our team also follows industry standards such as transcelerate initiatives for developing common content.

Editing and quality assurance

:

;

Medical writing also involves the review and editing of scientific documents to ensure accuracy, clarity and compliance with relevant guidelines and standards. If you need an external dispassionate review of your documentation, you can count on us to get the most out of it.

Interdisciplinary collaboration

:

;

Our medical writers work closely with researchers, statisticians, regulatory experts and other professionals to ensure that documents are scientifically accurate and appropriate for the intended audience.

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Benefits of our service

Elevating clinical research with premier documentation expertise

Embrace the advantages of Wemedoo’s medical writing service in your clinical trials for a streamlined, efficient documentation process. Our service guarantees high-quality, clear, and concise documentation, meticulously crafted to meet stringent regulatory standards. By entrusting your documentation needs to our experienced medical writers, you not only save valuable time and resources but also ensure consistency and effectiveness in communicating complex clinical information.

High-quality documentation

We deliver impeccably crafted clinical trial documents that are professionally written, clear, and concise, adhering to rigorous quality standards and reflecting our commitment to excellence.

Time and Resource efficiency

Wemedoo saves you valuable time and resources by entrusting documentation tasks to specialized writers, allowing the clinical team to focus on core research activities.

Expertise in complex information

Through Wemedoo, you benefit from experienced medical writers who adeptly translate intricate clinical data and research into comprehensible and accessible documents, fostering better understanding.

Consistency across documents

We ensure uniformity in style, format, and content across all trial-related documentation, enhancing professionalism and clarity.

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 medical writing and documentation service

What types of documents do Wemedoo medical writing and documentation services cover?

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Our services encompass a wide range of clinical trial documentation, including clinical study protocols, study reports, regulatory submission documents and scientific publications. Additionally, our expert team provides all regulatory documentation and study plans covering our services.

How does Wemedoo ensure compliance with regulatory standards in medical writing?

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Our team stays updated with the latest regulatory guidelines and incorporates these standards into every document we produce, ensuring compliance with agencies like the FDA and EMA, as well as bodies like the International Conference on Harmonisation and TransCelerate.

Can Wemedoo handle medical writing for specialized or rare therapeutic areas?

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Absolutely. Our team of medical writers has diverse expertise across various therapeutic areas, enabling us to effectively handle writing for specialized and rare conditions.

What is the benefit of outsourcing medical writing to Wemedoo?

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Outsourcing saves you time and resources while maintaining your organizational flexibility. Our expert writers efficiently produce high-quality, compliant documents. This allows your team to focus on core research activities while we handle the complexities of medical writing.

How does Wemedoo maintain consistency and accuracy in medical writing?

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We follow strict quality control procedures, including thorough reviews and validations, to ensure consistency and accuracy in all our medical writing outputs.

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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 medical writing and documentation, 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, saving you time and money. Discover our other services, all focusing on innovation and excellence in clinical research.

Protocol Development

Clinical Data Management

Risk-Based Monitoring and Source Data Review

eTMF Setup and Administration

Biostatistics and Statistical Programming

CDISC-Compliant Dataset Generation

Ready to enhance your trial efficiency with our expert services?

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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

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