Communication is key to the success of your clinical development program.
It all starts with proper planning by identifying the key elements of your research and integrating them in the study protocol. A well-written study protocol obtained through our medical writing services will:
Increase the efficiency of its review by funders, regulators, IRBs/REBs, scientific reviewers, and journal editors
Improve its understanding and implementation by research investigators
Avoid the drafting of burdensome protocol amendments
Contact our medical writing specialists
The informed consent form is also central to your clinical research’s success, as it must be able to educate research participants about the proposed research project in terms they can understand and become a reference document.
Throughout the course of the research up to its completion, the timely communication of complete, accurate, unbiased research reports will also improve the informed decision-making regarding your therapeutic product, including:
Our Medical Writing Services
We offer end-to-end clinical research communications services.
We specialize in the development of clinical study protocols. Starting with only the clinical concept, we can determine the proper population dynamics, study design, and statistical strategy to ensure valid outcomes and compliance to the highest scientific and ethical standards.
Our team of experienced clinical research professionals will generate a broad range of documents throughout your study’s lifecycle:
- Study Protocols
- Case Report Forms
- Study Questionnaires
- Investigator Brochures
- Study Recruitment
- Material (advertisement, educational material)
- Informed Consent Forms
- Clinical Study Reports (Full, Supplemental, Abbreviated, Synoptic)
- Project Management Reports
- Safety narratives
- Clinical Trial Applications (CTA)
- Investigational Testing Applications (ITA)
- Investigational New Drug Submissions (IND)
- Investigational Device Exemptions (IDE)
- Abstract and Manuscript preparation
- Poster presentations
- Platform presentations
- Investor presentations
- Customized reports
Our Medical Writing Approach
At ethica, the research participant lies at the heart of all our study documentation. Our standard operating procedures follow the principles outlined in the most current guidance documents, internationally recognized ethics principles, and industry best practices.
Our Medical Writing Operating Procedures
ethica’s written operating procedures and practices on study protocol development are aimed at assessing and minimizing the risks involved in proposed human research. We develop study protocols in accordance with the requirements of North American and European regulatory agencies, ICH guidance (E6 and E9), as well as internationally recognized best practices such as the Transcelerate Biopharma template and the SPIRIT Statement.
We draft Informed Consent Forms (ICFs) that are consistent with the study protocol, the product information and the clinical trial agreement between the sponsor and the investigator to ensure that the information conveyed to research participants is accurate, understandable, and easy to read. All our informed consent forms are tested against the Flesch Reading Ease, and the Flesch–Kincaid Grade Level tests.
Clinical Study Reports are developed in accordance with ICH E3, CORE and the CONSORT Statement to ensure clear, transparent and accurate data reporting.
Using advanced graphics and data visualization technology, ethica can analyse and present your study results for a variety of purposes throughout the lifecycle of your clinical development program. Whether it is to present interim research results to stakeholders, prepare a poster presentation or publish an article, ethica’s data management team can help you let your data express itself. We can also assist you in drafting your manuscript in accordance with the International Society for Medical Publication Professionals Good Publication Practice (GPP) guideline.
Contact ethica CRO now for more information about our medical writing services.