Regulatory Medical Writing
Ergomed’s Comprehensive Regulatory Medical Writing Services
At Ergomed, we offer a wide range of regulatory medical writing services covering all clinical research phases, including noninterventional and real-world evidence studies. Our experienced team meticulously writes and updates critical regulatory documents, ensuring your clinical trials adhere to the highest compliance and quality standards. Our services include crafting Clinical Study Reports (CSR), synopses, protocols, Investigator Brochures (IB), and more. With a commitment to scientific excellence, we provide the robust support you need to drive successful therapeutic outcomes.
Enhancing Clinical Trial Documentation
Our comprehensive regulatory medical writing services span all phases of clinical research and noninterventional and real-world evidence. At Ergomed, we provide meticulous writing and updating of critical regulatory documents, ensuring your clinical trials meet the highest compliance and quality standards.
Our services include:
- Clinical Study Reports (CSR)
- Synopses and Protocols
- Investigator Brochures (IB)
- Investigational New Drug (IND) Clinical Modules
- Investigational Medicinal Product Dossiers (IMPD) Clinical Modules
- Informed Consent Forms (ICF)
- Child Assent Forms
- Narratives
- Summary Protocol or Results Study
- Study Registration on EU Clinical Trials Register
Ergomed’s Medical Writing Team:
Your Partner Throughout the Clinical Trial
Before Your Study Starts
At the outset of your clinical trial, Ergomed’s medical writing team is your best resource for drafting, reviewing, and quality-checking all essential documents. Our protocol optimization service coordinates internal and external experts to design your study and draft your synopsis/protocol, ensuring that every aspect of your research is meticulously planned and documented. We assist by writing or updating your investigator brochure, developing clinical modules for your IMPD or IND application, and drafting informed consent forms. We aim to set a solid foundation for your study, providing documents that meet all regulatory requirements and facilitate smooth trial progression.
During Your Study
As your study progresses, our team remains actively involved, ready to amend your protocol swiftly and efficiently. We ensure that ICFs and other critical documents are updated promptly to reflect changes or new information. Our medical writing experts are also available to support activities related to sharing progress updates with sponsors. This continuous support confirms that your study remains compliant and transparent, with clear communication at every stage.
End of Study: Clinical Study Report (CSR)
After your study, our streamlined processes, designed for maximum efficiency, enable us to deliver the CSR with narratives as quickly as possible after the final results are available. We continue to provide support until all appendices documents are completed and the CSR is published to electronic Common Technical Document (eCTD) compliant standards. We register your study results with the EU Clinical Trials Register. This comprehensive end-to-end service accurately documents your study’s findings, facilitating regulatory review and approval.
Expertise and Quality Assurance
Our medical writers are seasoned professionals with extensive experience in regulatory writing. Each writer stays current with the latest regulatory guidelines and industry best practices, ensuring that all documents meet the stringent requirements of regulatory authorities such as the EMA and the FDA. Our commitment to quality and precision guarantees that your documents will comply with regulatory standards and support the overall success of your clinical research program. We have a rigorous quality control process, which includes multiple rounds of review and editing, to verify the accuracy and consistency of all our documents.
Integrated Support for Seamless Documentation
At Ergomed, we believe in a collaborative approach to regulatory medical writing. Our medical writing team works hand in hand with other departments, including regulatory affairs, biostatistics, medical, project management, and data management teams. This seamless integration comprehensively aligns all aspects of your study and documentation. Our holistic approach enhances the efficiency and effectiveness of your clinical trials, providing you with reliable support from start to finish.
Tailored Solutions for Diverse Needs
At Ergomed, we understand that each clinical trial has unique requirements and challenges. That’s why our regulatory medical writing services are designed to meet your diverse needs. Our team can adapt our flexible solutions to your particular studies. Whether you need assistance with a single document or comprehensive support throughout your trial, Ergomed is committed to delivering high-quality, accurate, and timely documentation supporting your research objectives.
Ergomed’s regulatory medical writing services provide a thorough and expert approach to documenting all phases of clinical research. Our experienced team, unwavering commitment to regulatory compliance, and integrated support ensure that your clinical trials are documented accurately and efficiently, facilitating regulatory compliance and the successful advancement of your research.
U.S. Presence, Ergo, Convenient to Biotechs
Our Complementary Services
See how Ergomed can support your clinical trial.
More Ergomed Services
Find out how Ergomed supports your clinical trial objectives.
Discover Our Latest Insights
Access Ergomed's resources for the latest in clinical trial trends and innovations.