top of page

Medical Monitoring & Safety Expertise in Oncology and Rare Diseases

Investigadora médica trabajando en un laboratorio moderno, enfocada en el análisis de muestras biológicas. La imagen refleja
Investigadora médica trabajando en un laboratorio moderno, enfocada en el análisis de muestras biológicas. La imagen refleja

Medical Monitoring & Safety Expertise in Oncology and Rare Diseases

OncoRare MD Advisory delivers high-impact consulting services focused on medical monitoring, safety oversight, and benefit–risk analysis for innovative oncology and rare disease programs. With over 20 years of clinical research experience, we support biotech companies, CROs, and academic sponsors in advancing therapies with scientific rigor and regulatory confidence.

Services

Medical Monitoring & Safety Oversight

  • Real-time safety data review and signal detection

  • Medical review of narratives and adverse events

  • Participation in study team and safety review meetings

  • Protocol and eligibility medical review

  • Cross-functional medical support

Narrative Development & Strategy

  • Writing and medical review of submission-ready narratives

  • Strategy for complex oncology safety profiles

  • Quality control of CRO-generated content

Strategic Safety Consulting

  • Risk Management Plans (RMPs), REMS, and signal management

  • Development of Safety Data Review Plans (SDRP)

  • Benefit–risk evaluation frameworks

  • PV strategy for rare diseases and small populations

Oncology & Rare Disease Support

  • Trial design input for early- and late-phase studies

  • Advisory board strategy and content development

  • Literature reviews and regulatory document preparation

Clients

Ideal Client Scenarios:

  • Need interim medical monitor coverage

  • Require expert narratives for oncology trials

  • Launching rare disease programs with safety complexity

We Work With:

  • Emerging biotechs and pharma companies

  • Contract Research Organizations (CROs)

  • Academic research networks

  • Global medical affairs and PV teams

Client Testimonials

"OncoRare MD Advisory brought immediate value and clarity to our clinical safety operations. Dr. Nieto’s insights shaped both our regulatory strategy and internal training."

VP, Clinical D

evelopment

"OncoRare MD Advisory brought immediate value and clarity to our clinical safety operations. Dr. Nieto’s insights shaped both our regulatory strategy and internal training."

VP, Clinical D

evelopment

"OncoRare MD Advisory brought immediate value and clarity to our clinical safety operations. Dr. Nieto’s insights shaped both our regulatory strategy and internal training."

VP, Clinical D

evelopment

Our Clients

Let’s Talk

Want to learn more about our solutions? Talk to our experts.

bottom of page