Scendea provides technical/medical writing services for Protocol development, including clinical or non-clinical/toxicology studies and Protocol Synopsis.

Scendea specialises in the authoring of Clinical Study Reports (CSRs), meticulously adhering to the guidelines outlined in ICH Guideline 3, "Structure and Contents of Clinical Study Reports" and Drug Safety Update Reports (DSURs).

Scendea excels in preparing core documents, including Investigator's Brochures (IBs). These meticulously prepared documents are crucial for enlightening investigators and trial stakeholders on essential protocol details, such as dosage, administration methods, dose frequency/interval, and safety monitoring procedures. Our proficiency in Regulatory Guidelines guarantees that your IB aligns seamlessly with standards, encompassing critical non-clinical aspects.

Scendea provides specialised support for IND/NDA/BLA and MAA licensing applications, offering expert review, revision, and authoring of Modules 2.5, 2.7 and 5, including sign off/expert assessments.