Medical Writing

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Medical Writing
Felicitous and competent documentation is vital for the success of clinical
development program. So, the current scenario in the clinical research industry is, every
organization leers for a befitting services to enhance its clinical study documentation
requirements through best Medical Writing companies across the globe.
Our Medical writing Environment
Our A-Z team of zealous medical writers is ingenious across all
therapeutic areas as well as hot segments like recombinant products. We
also cover all phases of clinical trials over all with bioequivalence and
preclinical. Our writers has executed high end quality documents ranging
from IBs and clinical trial protocols, through clinical narratives , aggregate
reports like DSURs / ASRs to CSRs and eCTD components.

Our Team and Strength

Our medical writing team has an exclusive brew of medical
and paramedical professionals with ample experienced writers from
clinical research, medical practice and the pharmaceutical industry.
Our medical writing consultant team have tenacious cogent and
interpretation ability, along with a strong knowledge of clinical trial
design and biostatistics. Our team has a good experience in word
processing, editing and bibliographic applications.
Our Experience
We draft wide range of documents for clinical trial submissions and other
regulatory documents yoke with clinical research. The documents we cover are
investigators brochures, study protocols, Informed consent, patient narratives, safety
narratives, CSRs, selected eCTD modules, development safety update reports (DSURs),
periodic safety update reports (PSURs) and annual safety reports (ASRs).

Our Uniqueness
Adherence with regulatory compliance like FDA, EMEA, etc.

Trained personals on ICH GCP guidelines, AMA writing styles, medical dictionaries
like MedDRA etc.

We have precise writers experienced on publication-related standards like GPP,

ICMJE , CONSORT, QUORUM, MOOSE, STARD, STROBE, TREND, ethical
considerations in the conduct and reporting of research.
What Medical Writing services we offer?
Regulatory and Clinical Writing
ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for
public disclosure
Study Protocols
Clinical and non clinical sections of the Common Technical Document (CTD) including
summaries and overviews for EU or US Regulatory Authorities
Investigator Brochures
Patient safety narratives
Patient information including Informed Consent and Patient Brochures
Pharmacovigilance documents such as Periodic Safety Update Reports
Standard Operating Procedures (SOPs) covering all aspects of drug development including
the design, conduct and reporting of clinical trials and the outsourcing of Sponsor
responsibilities to a Contract Research Organization (CRO).
Pharmacovigilance Medical Writing

Risk Management Plan production, review and maintenance

Pharmacovigilance System Master File (PSMF)
Company Core Safety Information (CCSI) production and maintenance
Regulatory Intelligence
Monthly compliance and status reporting
Pharmacovigilance Awareness Training
Reconciliation of Serious Adverse Events
Risk Management
Study documentation review and update, including protocol and Investigators Brochure
 CONTACT INFORMATION

ADDRESS:
No.6/387(First Floor),
6th Street Mogappair East,
Chennai, Tamil Nadu-600037, India
NUMBERS:

Phone : 044-49595223
Mobile : +91-9940084145
Email : info@cognibrain.com, project@cognibrain.com

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