Skip to content
Precision for Medicine
Contact Us
Press Release

FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients

Read the release
shutterstock_2437432971 (1)

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

Elevate your documentation with our integrated approach. 

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.

Why choose our Medical Writing services?

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.

Seamless integration with clinical trials management

As a full-spectrum contract research organization, medical writing is just one of the many services in which Precision excels. This ensures seamless integration with your broader clinical trial management needs.

shutterstock_2145486415

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* 
  • Precision FSP Managed Solutions

    Full-Service Medical Writing

    Seamless integration of Medical Writing into your full-service, Precision-managed study for complete and cohesive execution.

    Full-Service Medical Writing

    Seamless integration of Medical Writing into your full-service, Precision-managed study for complete and cohesive execution.
  • Explore
    Medical Writing

    FSP Medical Writing

    Integrate customized and focused Medical Writing expertise to enhance your project's capabilities and scale efficiently.
    Explore

    FSP Medical Writing

    Integrate customized and focused Medical Writing expertise to enhance your project's capabilities and scale efficiently.
    Explore

Spotlighting success:
Real-world challenges, Precision solutions

Explore how Precision for Medicine's medical writing experience played a pivotal role in driving clinical trials to completion.

  • Metastatic Cancer

    Metastatic Cancer

    Cross-Functional Excellence in the Face of Tight Deadlines for Metastatic Cancer

    • Indication: Unresectable Locally Advanced or Metastatic Cancer  
    • Services Provided: Protocol Development 
    • Challenge: Tight Submission Timelines 
    • Solution: Cross-functional teams ensured high quality and on-time submission 

  • Safety Reporting

    Safety Reporting

    From Complexity to Clarity: Harnessing Multidisciplinary Expertise for Unified Safety Reporting

    • Indication: Acute Lymphoblastic Leukemia, Lymphoblastic Leukemia, Adenoid Carcinoma, and Triple Negative Breast Cancer 
    • Services Provided: DSUR Development 
    • Challenge: Safety summary across multiple studies during a single reporting period 
    • Solution: Multidisciplinary approach captured study data in tables in accordance with ICH E2F and summarized safety data for DSUR 

  • Multiple Myeloma

    Multiple Myeloma

    Navigating Multiple Myeloma CSRs with a Dedicated Medical Writer

    • Indication: Multiple Myeloma 
    • Services Provided: Clinical Study Report Development 
    • Challenge: Multiple CSRs Over a Period of Several Years 
    • Solution: Maintained consistency across CSRs by using the same Medical Writer for each interim and final CSR 

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.

Explore our blog

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 accelerate speed to market. Precision can customize and converge our capabilities to meet your program's unique needs—driving efficiency, agility, and success from start to finish.

  • Discover Explore
    clinical-trial-support

    Global CRO
    Services

    Award-winning CRO with deep oncology and rare disease expertise

    Explore
  • Discover Explore
    specialty-lab-services

    Global Laboratory
    Services

    Exceptional translational and biomarker sciences with global central lab services

    Explore
Loading...