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

* 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 turn around time for every final report.  

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