Medical Writing Services Offered by CRO’s

Medical Writing Services Offered by CRO's
Medical writing has become an essential part of the pharmaceutical industry today. The key qualities of
an able medical writer are possessing flawless English language skills, having a flair for writing, having
the capability to represent medical information precisely and identifying the audience. Other qualities
include commitment to quality work, possessing team skills and the capacity to meet deadlines.
Generally it is the Clinical Research Organizations (CRO) and other communication agencies that hire
medical writers in a recurrent basis. These CRO's offers medical writing services for the whole clinical
trial development program.
The kind of work that the medical writer needs to do differs from one institution to that other. Medical
writers associated with CRO's and pharmaceutical organizations are generally involved with regulatory
document preparation. On the other hand, writers who are associated with communication agencies
deals in preparing marketing and promotional documents. Medical writers also take interest in
preparing scientific documents at every level of drug development, for which medical companies have a
separate division of expert medical writing teams. Sometimes these writers are involved in consultancy
services, for offering data on document, regulatory requirements, templates, product styling and
branding, protocol information, quality control as well as the product marketing and presentation.
However, senior and experienced Medical Writers are adept on managing additional responsibilities for
instance offering information in drug development programs, data analysis, trial designs and many
others.
Medical institutions and CRO's in India have their medical writing teams that are experienced and
qualified to cater to the needs of multiple regulatory report guidelines. The teams here assure that all
the important regulatory submission documents are concise, clear and are accurate both medically and
scientifically. They also ensure that it is compliant with all applicable regulatory and ICH guidelines with
submission reports offered in eCTD and CTD formats. The team in trained well in combining abstracts,
manuscripts and publications. The main medical services consist of the following:-
Protocol
Investigatigator brochures
Informed consent documents
Case report forms
Study reports
Common Technical Documents
eCTD
Scientific papers for publication
Med X view for e filing
Submission-ready documentation (Hyperlinked eCTD formatting)
Clinical reporting
Clinical study reports
Integrated safety and efficacy reports
Pharmacovigilance and safety reports
Presentations, posters and manuscripts

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Scientific papers and abstracts

Eminent CRO's in India has successfully demonstrated the experience in catering to international
reporting requirements for Medical Writing, as specified by numerous sponsors and agencies. Hence,
one can expect a quick turnaround time for every final report.


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