Ergomed’s Medical Writing Team Delivers High-Quality Documentation
Informed Medical Writing to Optimize Implementation and Regulatory Acceptance
At Ergomed, we understand that clarity, accuracy, and quality are paramount. Our experience, history, and knowledge enable us to deliver quality documents quickly. Our 24-hour service, made possible by our global team, allows us to work on your projects around the clock. This shortens timelines and ensures efficient project management, relieving you of any project deadline worries.
Our medical writing team, with its formidable experience in pediatric oncology and rare disease trials, is a testament to Ergomed’s patient-centric approach. But what truly sets us apart is our collaborative spirit. We don’t just work in isolation but hand in hand with colleagues across Ergomed—including regulatory, biostatistics, medical, project, and data management teams—to provide efficient and comprehensive medical writing services.
Regulatory Medical Writing
Our medical writing services span the entire development cycle and the full spectrum of regulatory documentation from clinical to noninterventional trials, including:
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Comprehensive documentation of clinical trial results, essential for regulatory submissions and publications.
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Detailed study plans that outline the methodology and objectives of clinical trials.
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Summaries of clinical and nonclinical data on investigational products to support clinical trial conduct.
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Documentation is required to initiate clinical trials in the United States. Clinical Modules: CTD 2.5, CTD 2.7.1, CTD 2.7.2, CTD 2.7.3, CTD 2.7.4, CTD 2.7.5, CTD 5.2.
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Essential documents for European clinical trial applications. Clinical Modules: CTD 2.5, CTD 2.7.1, CTD 2.7.2, CTD 2.7.3, CTD 2.7.4, CTD 2.7.5, CTD 5.2.
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Clear and comprehensive forms to obtain informed consent from study participants.
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Age-appropriate consent forms for pediatric participants.
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Detailed accounts of Serious Adverse Events (SAEs) experienced during clinical trials are crucial for safety reporting and regulatory compliance.
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Plain language summaries of clinical trial results provide transparency and inform the public, patients, and healthcare providers.
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Assistance with registering clinical trials in the European Union Clinical Trials Register, ensuring compliance with EU regulations and facilitating transparency and accessibility.
Stand-Alone Medical Writing
Our medical writers have broad experience completing partial documents, writing new documents from scratch, and working with external teams when needed. Our stand-alone medical writing services include:
Advice on Document Structure
Guidance on optimal organization and presentation of your documents.
Study Design
Expert input on the design and methodology of clinical studies.
Completion of Documents
Assistance with finalizing and refining clinical documents.
Protocols, Informed Consent Forms, Investigator Brochures
Development of essential clinical trial documents.
Protocol Synopsis for Investigational New Drugs
Concise summaries of clinical trial protocols for new drugs.
Clinical Study Reports
Detailed reporting of clinical trial findings.
Literature Reviews
Comprehensive reviews of existing research to support clinical trials and regulatory submissions.
Partner With Ergomed for Reliable, Expert Medical Writing
At Ergomed, our medical writing services support every phase of your clinical research program. Our commitment to quality, accuracy, and collaboration ensures that your documents comply with regulatory standards and contribute to the overall success of your clinical trials—partner with us for reliable, expert medical writing that drives your research forward.
Strong Science, Ergo, Deep Understanding
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