Clinical Directions offers two main services: medical writing and clinical development consulting.
Medical Writing & Study Document Support
I deliver high-quality regulatory and clinical study documents, in accordance with regulatory guidelines and ICH standards, that meet or exceed project timelines and client expectations. Documents I have worked on include:
- protocols
- clinical study reports
- informed consent forms & assent forms
- clinical study documents
- project plans
- investigator brochures
- annual reports
- document QC / peer review
- CRF completion guidelines
- laboratory manuals
- SOPs, work instructions & associated forms
- document templates
- poster design
- journal articles
Clinical Development Support
I consult with clients on strategy and design as well as supporting your ongoing clinical operations activities. I can also provide short-term assistance when you need help right now!
- project/study startup & support
- strategic planning
- project management
- CRO and specialty vendor identification & oversight
- RFP management
- IRB/IEC submissions & oversight
- problem solving and project support
- risk assessment & quality management systems
- team mentoring & coaching
- budget & timeline tracking
- CRA oversight
- TMF quality control
- monitoring visit report development & review
- IP packaging & labeling review
Multimedia
In addition to medical writing and clinical development consulting services, I coordinate with an outside company to provide graphic- and multimedia-design services for clinical development clients, such as press-ready scientific posters and site training videos for projects with complex clinical procedures.