To be granted regulatory and ethics committee approvals to perform a clinical trial, the Clinical Trial Dossier (CTD) and all its component documents must not only adhere to applicable guidelines and legislation but must also be written to the best possible quality standards. Medical writing skills are central to this.
At SMS-oncology we use a multidisciplinary team with proven medical writing skills to ensure the content, accuracy and presentation of any document meet the highest quality standards. Our medical writers carry this out with input from consultancy, medical affairs and clinical operations teams.
Tasks involve anything from drafting, reviewing, updating to full writing of regulatory documents, supporting our sponsors with high-quality documents that meet all GCP and industry standards, including:
- Investigational Medicinal Product Dossier (IMPD)
- Investigational New Drug (IND) file
- Investigator Brochure (IB)
- Clinical study synopsis
- Clinical study protocol
- Study-, country- & site- specific master informed consent forms (ICFs)
- ICH E3 compliant clinical study report (CSR)
Have you prepared a (draft) oncology protocol, but need to confirm that your study design will meet your study objectives? Do you think your oncology protocol includes the right methodology, but would you like a second opinion on whether it is (clinically) feasible and is time- and cost-effective? Or would you like to know if the scientific rationale is translated into a trial design that will ensure the right clinical data are collected to obtain proof of concept?
If you have any of these or other questions, we are here to offer a free and confidential review of your planned early phase oncology trial (draft) protocol, and provide you with comprehensive, strategic and clinical recommendations. Our advice will take into account the unique properties of your drug, the competition, and the medical need it will serve. We provide input on the design, methodology, objectives, eligibility criteria, background, rationale and practical organization of your study.
Being one of the most essential documents in clinical trial conduct, our advice contributes to a high-quality (draft) study protocol whose execution is feasible and will provide you with the clinical data you need to be successful in the development of your oncology compound.
By providing advice on your protocol, we intend to give you an initial impression of our in-house expertise and capabilities with no obligation to work with us in the future. This allows you to experience our unique way of providing direction (proactive guidance) firsthand, as we understand the challenges of developing anti-cancer drugs in a highly competitive market. We believe this will be beneficial not only at project level, but at a higher organizational level too.
Expert protocol advice (free service)
In addition, we offer a free and confidential review of the of your planned early phase oncology trial (draft) protocol, thereby providing you with comprehensive, strategic and clinical recommendations.