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Clinical Trials - Gene Therapies
Long-term Follow-up Studies: Gene Therapy Products, Protocols and Potential Issues
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Medical Writing experts transform complex clinical data into documents that support regulatory submissions and meet stringent global requirements.
With impeccable attention to detail, we leverage comprehensive expertise from cross-functional teams including Biostatistics, Medical Monitoring, and Regulatory Affairs to ensure each document meets quality and regulatory standards, delivering unparalleled scientific excellence.
Expertly crafted protocols leveraging scientific expertise for clear, precise stakeholder communication and stronger clinical outcomes.
Informed Consent Forms (ICFs)
Facilitating participant decision-making through transparent and comprehensive informed consent forms.
Meticulously created guides that present latest trial data and safety profiles, and are designed to efficiently communicate advancements through the course of development.
Expertly written annual reports capturing clinical trial progress and critical safety updates, designed to meet regulatory standards for monitoring and reporting the evolving safety profile of the investigational new drug.
High-quality CSRs and CSR patient narratives that provide a clear, concise, and scientifically-driven representation and key messaging of the clinical study data and critical safety outcomes.
Precision-crafted submission-ready and fit-for-purpose clinical documents that facilitate the application process, optimized for both local and international regulatory submissions.
Comprehensive Summary Documents, Integrated Summary of Safety, Integrated Summary of Efficacy and Clinical Overviews, for FDA submissions, adaptable for supporting submissions to various regulatory authorities including EMA, Health Canada and PMDA.
We’re committed to excellence, ensuring every piece mirrors your research with precision. In-house medical writing experts have an average of 10 years of experience, and adhere to standardized processes and ICH-compliance.
Our teams maintain close interactions with clinical, biostatistics, and regulatory teams to ensure that all perspectives are integrated, which results in a holistic and comprehensive final product.
Over the past four years, we’ve championed a diverse range of indications, propelling forward with dedication and expertise. With every document, we further our commitment to shaping the clinical trial messaging and helping our partners stay ahead in the evolving landscape of clinical research. Here’s a snapshot of our latest achievements:
We have been delighted with the experience level and work product from the entire project team – they feel like an extension of our internal team.
I recognize that relations between Sponsors and CRO vendors can be strained and difficult, often a blaming game; this has never been my experience with this group as it truly felt like a partnership.
Our partnership with Precision is a true textbook definition of a great collaboration between a sponsor and a CRO.
At so many levels, the Precision for Medicine team has been fantastic. I am very grateful for how responsive and how collaborative the whole team is. Very grateful for their help.
Explore how Precision for Medicine's medical writing experience played a pivotal role in driving clinical trials to completion.
Metastatic Cancer
Cross-Functional Excellence in the Face of Tight Deadlines for Metastatic Cancer
Safety Reporting
From Complexity to Clarity: Harnessing Multidisciplinary Expertise for Unified Safety Reporting
Multiple Myeloma
Navigating Multiple Myeloma CSRs with a Dedicated Medical Writer
Explore the insights of in-house experts to learn about the evolving role of medical writing in driving patient-centricity in clinical research.
Clinical Trials - Gene Therapies
Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to increase speed to market. Incorporate manufacturing expertise for advances therapies to ensure scalability. Precision can customize and converge our capabilities for your program's unique needs.
Award-winning CRO with deep oncology and rare disease expertise
Exceptional translational and biomarker sciences with global central lab services
Pioneers in planning, building and maintaining manufacturing at scale for pharma and biotechs.