Title: Medical Writing Services
1(No Transcript)
2Role of a Medical Writer InClinical Research
3Clinical trials are important For The new drugs
to come into the Market
4Conducting AClinical TrialIsNot the endOf
Clinical Research
5Research Data Has toBePresentedInClearConcis
eManner
6Who does this job?
7- Research Scientists
- Doctors
- Statisticians
- Regulatory professionals
- Medical writer
8What does a medical writer do?
- Prepares scientific documents of highest quality
meeting all applicable regulatory requirements
9Industries requiring medical writing services
- Pharmaceutical Industry
- Clinical Research
- Pharmacovigilance
- Healthcare
10Documents prepared by medical writer
- Research proposals
- Investigator brochures
- Informed consent documents
- Clinical study reports
- Clinical trial protocols
- Package inserts
- Patient information leaflets
- Patient safety narratives
11Who is the best medical writer for you?
- Has knowledge of drug development process
- Has knowledge of regulatory requirements like
FDA, EMEA etc. - Understands the purpose and requirement of the
task - Can logically organize thoughts and ideas
- Has good coordination with stakeholders or team
12What else to look for?
- Training in AMA writing style
- Experience in publication related standards
- Ethics in conduct and reporting of research
13How to avail a competent medical writer?
14Consult a Medical Writing Companies
15Medical Writing Company Offers
- Zealous medical writers across all therapeutic
areas - Medical writers trained in AMA style of writing
- Medical writers experienced in publication
standards and regulatory requirements - Regulatory and Pharmacovigilance medical writing
16E-mail project_at_cognibrain.com
Phone 044-49595223 URL www.cognibrain.com/