Medical Writing

Protocol development & Authoring

• Protocol development is one of the most essential parts of overall clinical development and requires an utmost understanding of regulatory requirements besides deep therapeutic and statistical understanding. 
• Genpro medical writers not only support the authoring but drives the process to integrate expert advice from various line functions and effectively contribute throughout the protocol development process. 
• Our integrated biostatistics line-function will work seamlessly to provide expert advice to meet with complex study design while balancing global requirements.

Investigator’s Brochure [Initial & updates]

• Right from initial IB authoring, active involvement of various line functions is critical for producing concise and clear document meeting regulatory needs while conveying the required information to the investigator in a comprehensive manner. 
• Genpro medical writers are experienced and trained to handle the initial IB version followed by annual updates and drive the process compliant to most recent CTFG guidelines and any other special requirements based on type of the development program. 
• Biostats & Programming teams work closely with MW to provide wide coverage of services so that clients can focus on clinical and safety aspects.

Clinical Study Reports

• CSRs are essential building blocks of any submission and even critical for disseminating the study findings to the regulators in a timely and transparent manner. 
• At Genpro, our writers carry a huge experience of authoring ICH E3 compliant clinical trial reports in a dynamic manner integrating varied therapeutic area understanding. 
• Our clients focus on operational aspects of the study while our integrated MW, Bio-states and programming team takes care of analyzing the data and reporting while working as an extended team part of the clinical development function. 
• Patient Narratives are an integral part of the CSR and key component of the safety presentation. Narratives are also often required part of many other summary documents and even for adjudication committees. Genpro writers understand the importance of comprehensive yet concise presentation in each narrative and can provide crucial suggestions to the client teams both in regulatory requirements and medical relevance while planning and/or authoring of narratives. We strive to provide a solution which is optimally balanced between regulatory needs and transparent accurate reporting of individual patient narratives which are medically reviewed in an objective manner.

Abstracts, Manuscripts, and scientific communications

Systematic Literature Review and Meta-analysis

• Performing well-planned SLR and Meta-analysis can general useful insights and support a wide range of decision-making and techno-commercial branding activities. 
• At Genpro we provide not only authoring support for SLR but also extend expert consultation at all stages of the project conceptualization till execution. 
• The AI-ML based tools developed by Genpro’s internal product teams provide unparalleled advanced understanding and speed for designing and conducting SLR.

Risk Management Plan (EU and Global RMP)

• RMPs are considered as one of the foremost important regulatory safety documents and are legally binding to the license or marketing authorization holder. 
• At Genpro we understand the nitty-gritty of the overall risk management and diligently balance regulatory requirements vs speed and accuracy required during RMP authoring and updates. 
• Genpro can provide integrated epidemiology, programming, authoring, and medical review support for EU-RMP and Global RMP while working closely with clients’ teams for local RMP implementation. 

Aggregate safety reports and other PV deliverables

• PSUR/PBRER, DSUR, and other periodic aggregate reports are vital regulatory requirements covering the entire product life cycle and hence require functional expertise while creating them. 
• Genpro safety writers carry a deep understanding of aggregate reporting and also evolving safety profiles based on staged of the clinical development or use of safety data from marketing. 
• We can function as a bridge between your PV and MW team while liaising closely with regulatory, clinical and other stakeholders required for these multifaceted reports.

Standalone QC and Medical reviews

• Quality is the core of overall reporting with any of the regulatory agencies or writing for other audiences. Speed of authoring and multiple reviews may lead to inconsistencies or even incorrect data/messaging within documents which may lead to significant regulatory delays/denial or even can affect the reputation and credibility of the sponsor. 
• At Genpro, we believe in robust quality monitoring of all inhouse documents that we create for our clients and can also become an expert external QC agency for robust detailed medical or scientific reviews and data checks. 
• Owing to huge experience Genpro MW team handles QC of any document type at unprecedented speed with high accuracy and thus has become partners in success full submissions for may global organizations.