Superior Scientific, Clinical & Medical Writing.
Medical writing is a pivotal part of clinical research and drug development. A well-developed medical or regulatory document strengthens the research while an under-developed document can ruin the efforts of years long research. So, it is wise to invest in a team of expert medical writers who can deliver accurate, compliant and highest quality clinical and regulatory documents within time.
Global Pharma Tek, a CRO, offers a wide range of Clinical research services including Medical Writing spanning from individual documents to extensive medical writing programs for the biotech, pharmaceutical and medical devices companies across the globe. Our team consists of qualified medical, pharma and life science members including MBBS, MD, Masters, and PhD holders who can prepare error-free documents and reports for regulatory bodies.
Our Comprehensive range of services include the following:
|Scientific Writing||Regulatory Writing||Safety Writing||Clinical Writing|
|Medical educational and training materials||CTD/eCTDs||AE/SAE Narratives||Clinical study reports|
|Medical marketing reviews and reports||INDs, IDEs, NDAs, ANDAs, BLAs, PMA, MAA||Causality Assessments||Informed Consent forms|
|Literature reviews||CMC/manufacturing reports||Analysis of Similar Events||Clinical Study Protocols, SOPs, Templates|
|Publication planning||Aggregate periodic safety reporting (PADER, PSUR/PBRER, ASR/DSUR)||· Case Report Forms (CRFs)|
|Abstracts, Manuscript, Posters, Brochures and Slides||ICSR narratives||Investigator brochures (IBs)|
|Journal/conference submission||Dear HCP letters||Clinical Development Plans (CDPs)|
|Risk benefit assessments||Orphan Drug Designation (ODD)|
|Signal Evaluation reports|
|Health hazard evaluations|
Expertise to Transform Complex Data to Accurate Data
The expert medical writers of Global Pharma Tek become an indispensable extension of client’s team and logically transform the diverse and complex data into an accurate and reliable data without any compromise on quality and compliance. The clinical as well as regulatory documents are quality reviewed to ascertain highest scientific standards.
Wide Breadth of Clinical & Regulatory Knowledge
Our years of experience, proficiency in therapeutic areas and extensive understanding of FDA, ICH-GCP, EMA guidelines give us an edge in medical writing. With constantly updating clinical and regulatory guidelines, we keep ourselves equipped for our clients to fasten their clinical process without any hassles.
Tailored & Full Range of Medical Writing Services
We offer full range of medical writing services and can also tailor them as per your needs. Our medical writers can conveniently work on individual documents and can also create extensive documents as per client specifications.
Rigorous Quality Assurance
Medical and regulatory documents are very crucial for success of clinical research. The documents need to be compliant with all the regulatory requirements. Our rigorous quality check processes at every step ensure that all regulatory specifications are met to deliver quality material for our clients.
Integrated Team Work
Our team of medical writers work closely with client’s team and other members including Biostatistician, Operations manager, Pharmacovigilance experts, Data managers etc. for a transparent and open access to information, so as to create concise, clear and high-quality documents and reports.
Well Communicated Progress
We understand and consistently follow the timelines provided by our clients. All events during the project are recorded and the clients are duly informed of the progress. Our team of medical writers ensure the usage of best language that clearly communicates the findings while adhering to the standards and guidelines of scientific and medical writing.
Preferred Global Medical Writing Consultancy
We are the preferred medical writing partners of our renowned clients since years. Our cost-effective services are open for projects of different scale and scope. We ensure maintenance of best quality and regulatory standards throughout the research with our services.