Felicitous and competent documentation is vital for the success of clinical development program. So, the current scenario in the clinical research industry is, every organisation leers for a befitting services to enhance its clinical study documentation requirements through best medical writing services across the globe.
Our Medical writing Environment
Our A-Z team of zealous medical writers is ingenious across regulatory medical writing and 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 companies 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 have tenacious cogent and interpretation ability, along with a strong knowledge of clinical trial design and bio-statistics. Our medical writing services team has a good experience in word processing and bibliographic applications.
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). Cognibrain has managed more than thousand writing project in many countries like USA, UK and India.
- 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 Organisation (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 Investigator’s Brochure