The importance of proper document development and submission in regards to clinical research is vital to the success or failure of new pharmaceuticals and devices. Our company offers a variety of medical writing solutions to help with clinical study development, documentation and submission of Phase I through Phase IV clinical study reports. Further, our writers are able to assist with the development of clinical study protocol, clinical study reports, investigator brochures, patient narratives, Data Safety Monitoring Boards (DSMB) updates, regulatory submission and more.
Our team of medical writers has extensive experience writing across a variety of therapeutic areas. They are qualified to help you research, organize, write, edit, and produce a variety of medical documentation that is needed to aid your pharmaceutical or device development. We offer flexible solutions for projects of all sizes.
Types of documents and submission that our writers can help you with include:
- Clinical development plans
- Clinical study protocols
- Clinical study reports
- Clinical study report appendices
- Case report forms
- New drug applications (NDA)
- Marketing authorisation applications (MAA)
- New drug submission (NDS)
- Premarket approval (PMA)
- 510(k)
- Investigational new drug (IND)
- Investigational medicinal product dossiers (IMPD)
- Investigational device exemptions (IDE)
- Define/CRT documents
- Investigation brochures
- Meeting packages
