Oncology Medical Writing Services
Specialized medical writing expertise for complex oncology trials and submissions across solid tumors, hematologic malignancies, and immuno-oncology.
Our Oncology Expertise
Comprehensive experience across the oncology drug development lifecycle
Expert writing for clinical trials and submissions across major solid tumor indications.
Specialized knowledge in blood cancer documentation and trials.
Advanced understanding of immunotherapy mechanisms and unique documentation requirements.
Why Choose EloquiMed for Oncology Writing
Our specialized team brings deep scientific knowledge and regulatory expertise specific to oncology drug development.
Specialized Expertise
Medical writers with advanced degrees in oncology, immunology, and related fields
Complex Trial Design
Experience with complex oncology trial designs (basket, umbrella, platform trials)
Endpoint Mastery
Understanding of oncology-specific endpoints (ORR, PFS, TTP, DoR, OS)
Assessment Criteria
Expertise in RECIST, iRECIST, and other specialized oncology assessment criteria
Treatment Landscape
Knowledge of current treatment landscapes across major tumor types
Precision Medicine
Experience with precision medicine approaches and biomarker development
Our Oncology Experience in Numbers
Oncology protocols and CSRs authored in the past 5 years
Oncology regulatory submissions supported (NDAs, BLAs, MAAs)
Oncology clinical development programs supported
First-cycle approval rate for oncology submissions we've supported
Oncology-Specific Services
Comprehensive documentation solutions for the complete oncology product lifecycle
Clinical Trial Documentation
Comprehensive support for oncology clinical trials from planning to completion.
Expert development of oncology protocols with appropriate design, endpoints, and safety considerations for all trial phases.
Comprehensive CSRs with expert interpretation of efficacy endpoints, biomarker data, and complex safety profiles.
Detailed IBs that effectively communicate MOA, preclinical data, and emerging clinical findings for novel oncology therapies.
Expert documentation for innovative trial designs including basket, umbrella, platform trials, and adaptive designs.
Regulatory Submissions
Strategic documentation for successful oncology product approvals.
Compelling Module 2.7 clinical summaries that effectively present benefit-risk profile for oncology therapies.
Strategic advisory committee and regulatory briefing materials for oncology products.
Expert documentation supporting breakthrough therapy, fast track, accelerated approval, and PRIME designations.
Specialized documentation for pediatric investigation plans and pediatric study plans for oncology products.
Medical Affairs Support
Scientific communications for oncology products throughout their lifecycle.
Strategic publication planning and development for oncology clinical trials and real-world evidence.
Scientifically accurate and compliant responses to healthcare professional inquiries about oncology products.
Evidence-based scientific narratives and value messages for oncology therapies.
High-quality abstracts, posters, and presentations for ASCO, ESMO, ASH, AACR and other oncology conferences.
Case Study: Accelerated Approval Success
How EloquiMed supported a successful accelerated approval application for a novel targeted oncology therapy
The Challenge
A mid-sized oncology biotech company was pursuing accelerated approval for their targeted therapy in a rare solid tumor indication based on a single-arm Phase 2 trial with compelling response rate data. The team needed comprehensive documentation support with an aggressive timeline to prepare for FDA submission.
Our Approach
- Assembled a dedicated oncology writing team with relevant indication expertise
- Developed a strategic narrative that highlighted the unmet medical need and treatment benefit
- Created custom visualizations to clearly communicate complex biomarker and efficacy data
- Prepared comprehensive documentation package including CSR, clinical summaries, and briefing materials
- Implemented parallel workstreams to meet compressed regulatory timeline
- Provided strategic support during pre-submission meetings and regulatory interactions
The Results
from last patient visit to submission
major deficiencies identified in submission
unanimous advisory committee vote
ahead of PDUFA date approval
"EloquiMed's oncology expertise was instrumental in communicating our complex data story to regulators. Their strategic approach and quality writing directly contributed to our successful accelerated approval."
Our Oncology Writing Team
Specialized writers with scientific and regulatory expertise in oncology drug development
PhD in Cancer Biology with 12+ years of experience in solid tumor clinical documentation and immuno-oncology regulatory submissions.
Board-certified hematologist with expertise in hematologic malignancies and specialized experience in CAR-T and cellular therapy documentation.
Former FDA oncology reviewer with 15+ years of experience in regulatory strategy and submission preparation for oncology products.
Ready to accelerate your oncology program?
Contact EloquiMed today to discuss how our oncology medical writing expertise can support your clinical development and regulatory success.
Related Resources
Learn more about oncology medical writing
