Medical Writing Simplified
Medical Writing
Medical Writers play an important role in Pharmaceutical industry, especially in Clinical Trial, and Pharmacovigilance domain. They are involved in preparation of different type of documents, reports like Protocol, Investigator’s Brochure (IB), Technical Document, Periodic Adverse Drug Experience Report (PADER), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), Pharmacovigilance System Master File (PSMF), Risk Management Plan (RMP), Clinical Study Report (CSR) etc.
Medical Writers come from diverse educational background and experience. Technological advancement and automation enable Medical Writer to generate reports instantaneously and focus their time and effort on review and finalization process.
How Technology Empower Medical Writers
Technology can help Medical Writer to improve efficiency by generating draft report instantaneously as per requirements and applicable regulatory guidelines.
Technology can save time by avoiding repetitive work and process automation. Medical Writers will have more time to focus on critical tasks instead of consuming their time and skill in manual drafting.
Technology can also improve quality of medical writing, by standardising data from different sources into structured format instantly.
Help in intelligence decision making by analysing large volume of data and instant data visualisation for decision making.
About PVWriter
PVWriter is a software application streamlining the entire process of aggregate report preparation, review and finalisation. The application is developed by technical experts, under supervision of domain experts with decades of experience. A fully validated application with inbuilt functionality to support data extraction, data analysis, natural language processing (NLP), and natural language generation (NLG), to produce aggregate report like PADER, PSUR, PBRER, DSUR etc. quickly as per regulatory requirements with minimal human intervention. The application has the ability to customise further to meet Client’s requirements. PVWriter helps Medical Writer to improve performance, by assisting their day-to-day works.
PVWriter Features
STREAMLINED PROCESS
Streamlined medical writing process starting from data collection, report preparation, peer review, medical review, approval and finalisation.
ENHANCED COMPLIANCE
Fully validated, access control, inbuilt audit trail to ensure compliance with regulations.
DATA PRIVACY
Robust data protection and compliance with worldwide data privacy regulations.
AUTOMATIC REPORT PREPARATION
Report generation in company report template by analysing the data and through intelligent decision making, with minimal human intervention.
AUTOMATIC DATA ANALYSIS
Inbuilt data analysis and validation function to extract data in a structured format.
DATABASE COMPATIBILITY
PVWriter is compatible with all Safety databases to sync or upload safety data.
PVWriter Benefits
ACCURACY AND COMPLIANCE
Reducing the risk of human error thereby improving compliance.
IMPROVED EFFICIENCY
Accelerate the writing process, leading to improved efficiency.
TIME SAVING
Cutting-edge solution that provides significant time and cost savings.
IMPROVED DECISION MAKING
Enabling intelligent decision making to enhance benefit-risk assessment.
The results have been nothing short of impressive, PVWriter can save 90% time by reducing manual effort by 90%.
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About GVP Technology
GVP Technology, a pioneering technology organisation dedicated to revolutionising Pharmacovigilance and contributing to the welfare of global healthcare.
We are product-based software company provides technology-driven product and solutions for the pharmaceutical industry. We stand at the intersection of technology and healthcare, leveraging the power of innovation to enhance Pharmacovigilance practices. We began to cater Pharma clients’ expectations aligned with regulations through a blended approach for enrichment of analytics of safety information adopting innovative technologies.
Contact Us
Our team would be pleased to answer any inquiries you may have and demonstrate how our application can transform your Pharmacovigilance system.
- GVP Technology Solutions Pvt Ltd
- A5 Ramasamy Nagar, Alapakkam New Perungalathur, Chennai 600063, India
- info@pvwriter.com
- www.pvwriter.com