Delve Medical Writing specialises in the development of clinical trial documentation, with a focus on early phase research.
Medical writers at Delve have extensive experience in the preparation of clinical trial documents including:
- Clinical Study Protocols (final provided approximately 5 weeks from receipt of approved synopsis);
- Clinical Study Protocol Amendments (final provided approximately 2 weeks from receipt of required updates);
- Clinical Study Reports (final provided approximately 8 weeks from receipt of final TFL’s);
- Investigator’s Brochures (final provided approximately 5 weeks from receipt of all supporting literature).
Delve specialises in document preparation for early phase trials conducted at dedicated study sites in Australia (CMAX, Linear, Nucleus). Delve is familiar with the different requirements for conducting studies at each of these sites. This knowledge assists in the efficient production of study documents for studies to be conducted at these sites.
Delve has a team of staff trained in Delve Standard Operating Procedures who assist with:
- Medical writing;
- Early phase strategic advice;
- Quality reviews.
Delve works closely with preferred providers who can provide the following services:
- Biostatistics advice and services;
- Pharmacokinetic advice and reporting services;
- Toxicology reviews of Investigator’s Brochures;
Delve can assist on a contract basis as the need arises with processes in place to ensure a confidential, secure and professional service is offered.