Therapeutic Area Expertise
Our medical writing team has extensive expertise across multiple therapeutic areas, enabling us to effectively communicate complex medical and scientific data clearly and accurately.
Our oncology expertise spans solid tumors, hematologic malignancies, and emerging immunotherapies, supporting clinical development programs from early phase to marketing authorization.
- Solid tumors and hematologic malignancies
- Immuno-oncology and targeted therapies
- Rare oncology indications
- Combination therapies and biomarker strategies
We have deep expertise in autoimmune and inflammatory conditions, including rheumatology, dermatology, gastroenterology, and respiratory indications.
- Rheumatoid arthritis and psoriatic arthritis
- Inflammatory bowel diseases
- Dermatologic conditions
- Respiratory inflammatory disorders
Our neurology expertise covers the full spectrum of central nervous system disorders, from neurodegeneration to pain management and psychiatric conditions.
- Neurodegenerative diseases
- Neuropsychiatric disorders
- Pain management
- Multiple sclerosis and neuroimmunology
We specialize in navigating the unique regulatory considerations and documentation challenges in rare disease development, including orphan drug designations.
- Orphan drug designation support
- Expedited program applications
- Small population trial design documentation
- Natural history studies and registries
Our team has extensive experience in cardiovascular and metabolic disorders, from common conditions to specialized therapeutic approaches.
- Cardiovascular disease prevention and treatment
- Diabetes and metabolic syndrome
- Lipid disorders
- Heart failure and cardiomyopathies
We support antimicrobial, antiviral, antifungal, and vaccine development programs with specialized medical writing and regulatory expertise.
- Antibacterial resistance strategies
- Antiviral therapies
- Vaccine development and documentation
- Emerging pathogens and pandemic response
Cross-Therapeutic Expertise
Specialized knowledge that spans multiple therapeutic areas.
Specialized documentation for pediatric investigation plans and pediatric studies across therapeutic areas.
Expertise in addressing the unique considerations for elderly patients in clinical documentation.
Support for biomarker-driven development programs and companion diagnostics documentation.
Documentation for digital therapeutics, drug-device combinations, and connected medicine products.
Medical Writing Excellence Across Therapeutic Areas
Our specialized expertise translates into high-quality documentation across all therapeutic domains.
Therapeutic Area Specialists
Our writers have advanced degrees and clinical experience in their specialization areas, ensuring deep understanding of disease biology and treatment mechanisms.
Current Medical Knowledge
We stay current on scientific advancements, regulatory changes, and evolving treatment paradigms in each therapeutic area through continuing education and conference attendance.
Customized Approach
We adapt our writing style and strategy to address the unique scientific, medical, and regulatory considerations of each therapeutic area and indication.
Document Expertise by Therapeutic Area
Our specialized teams provide comprehensive documentation support across the product lifecycle.
| Document Type | Oncology | Immunology | Neurology | Rare Diseases | Cardio-Metabolic | Infectious Diseases |
|---|---|---|---|---|---|---|
| Clinical Study Reports | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Protocols | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Investigator's Brochures | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Clinical Overviews/Summaries | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Regulatory Briefing Documents | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| DSUR/PSUR/PBRER | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Publications/Abstracts | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Therapeutic Area Case Studies
See how our expertise has supported successful product development across therapeutic areas.
We developed a comprehensive documentation package supporting accelerated approval for a novel therapy in relapsed/refractory multiple myeloma, resulting in successful FDA approval.
Our team created a comprehensive IB for a first-in-class monoclonal antibody targeting a novel immune pathway in autoimmune disorders, supporting successful Phase 1 initiation.
We developed a comprehensive Development Safety Update Report strategy for a complex neurodegenerative disease program with multiple ongoing clinical studies.
Ready to work with therapeutic area experts?
Contact us to discuss how our specialized expertise can support your specific program.