Robust Medical Writing with Precision
Leverage Precision's Medical Writing expertise to guide clinical science success
Medical writers are vested partners who understand the science, communicating it accurately and effectively to steer clinical data in clear directions.
Precision medical writing services for clinical trials
Medical Writing Services Overview
Protocol Services
Protocols, Protocol Amendments, and Summaries of Change
Expertly crafted protocols leveraging scientific expertise for clear, precise stakeholder communication and stronger clinical outcomes.
ICFs
Informed Consent Forms (ICFs)
Facilitating participant decision-making through transparent and comprehensive informed consent forms.
Investigator Brochures
Investigator's Brochures (IBs) and IB Updates
Meticulously created guides that present latest trial data and safety profiles, and are designed to efficiently communicate advancements through the course of development.
DSURs and IND Annual Reports
Development Safety Update Reports (DSURs) and Investigational New Drug (IND) Annual Reports
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.
CSR and Patient Narratives
Clinical Study Reports and Patient Narratives
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.
NDAs and BLAs
Marketing Application Summary Documents Specifically for NDAs, BLAs
Precision-crafted submission-ready and fit-for-purpose clinical documents that facilitate the application process, optimized for both local and international regulatory submissions.
ISS & ISE 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.
What sets Precision apart
An unwavering dedication to quality
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.
Streamlined and collaborative approach
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.
A medical writing track record that speaks volumes
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:
44
Protocols
9
Investigator Brochures
29
DSURs and IND Annual Reports
55
Clinical Study Reports
Medical Writing experience
Indications supported in the past four years
Oncology
- Adenoid Cystic Carcinoma (ACC)**
- Acute Myeloid Leukemia (AML)
- Advanced Hematological Malignancies
- Advanced Treatment-refractory
- Malignancies
- Glioblastoma
- Leukemia
- Melanoma
- Mesothelioma
- Metastatic Cancer (inc. Brain Metastases)
- Prostate Cancer
- Solid Tumors
- Small Cell Lung Cancer (SCLC)
- Non-small Cell Lung Cancer (NSCLC)
Rare Diseases & Others
- Alzheimer’s Disease
- Cataracts
- COVID-19
- Depression
- Treatment-resistant Depression
- Galactosemia*
- Myocardial Infarction
- Non-ischemic Heart Failure
- NLRC4/XIAP Deficiencies*
- Pain
- Pulmonary Disorders
- Transthyretin Amyloidosis*
- Eosinophilic Esophagitis*
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Full-Service Medical Writing
Seamless integration of Medical Writing into your full-service, Precision-managed study for complete and cohesive execution. -
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FSP Medical Writing
Integrate customized and focused Medical Writing expertise to enhance your project's capabilities and scale efficiently.
Spotlighting success:
Real-world challenges, Precision solutions
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Metastatic Cancer
Metastatic Cancer
Cross-Functional Excellence in the Face of Tight Deadlines for Metastatic Cancer
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Safety Reporting
Safety Reporting
From Complexity to Clarity: Harnessing Multidisciplinary Expertise for Unified Safety Reporting
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Multiple Myeloma
Multiple Myeloma
Navigating Multiple Myeloma CSRs with a Dedicated Medical Writer
Insights from our Medical Writing experts
Explore the insights of in-house experts to learn about the evolving role of medical writing in driving patient-centricity in clinical research.
Lean Authoring: Bringing Efficiency and Speed to Clinical Study Reports
Case Study: An Advanced Approach to Integrated Summary of Safety Studies
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Clinical Trials - Gene Therapies
Long-term Follow-up Studies: Gene Therapy Products, Protocols and Potential Issues
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Specialized capabilities in every stage of clinical development
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.
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Global CRO
ServicesAward-winning CRO with deep oncology and rare disease expertise
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Global Laboratory
ServicesExceptional translational and biomarker sciences with global central lab services
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Manufacturing
SolutionsPioneers in planning, building and maintaining manufacturing at scale for pharma and biotechs.
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Biospecimens
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Diagnostics & CDx
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Data Intelligence
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Commercialization
Tell us about your project requirements
An experienced medical writing team is just one of the many reasons to choose Precision for Medicine. Contact us to learn more.