Our Services and Methodology
We support clinical sites by confirming regulatory compliance and assisting them in preparing, editing, formatting, submitting, and tracking regulatory documents such as informed consent/assent forms, HIPAA notifications, and participant information sheets. We provide sites with a checklist of items required for the regulatory file, as well as template forms, such as Delegation of Authority and Financial Disclosure.
Our team of professional writers can assist clients with regulatory writing such as protocols and protocol amendments; patient information leaflets; clinical study reports; participant narratives; investigator brochures; integrated summaries of safety and efficacy; literature review summaries; clinical expert reports; Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), Clinical Trial Applications (CTAs), and Module 2 summary documents; IND and NDA annual reports; safety aggregate reports such as Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs); clinical trial registry synopses; scientific manuscripts; abstracts; and posters.
Work with us. Contact us to learn how we can find the right solutions for all of your clinical research needs.