Epidemiology Consulting Services for Pharma & Biotech: Real-World Evidence, Study Design, and Publication Support

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In a world where data drives approvals, partnerships, and payer access, mid-size pharmaceutical and biotech companies are under increasing pressure to generate robust, defensible, and publication-ready evidence—without the resources of Big Pharma.

You may be advancing a first-in-class therapeutic, leading a promising post-marketing program, or preparing to submit to regulators. Yet you face real constraints: lean internal teams, tight timelines, and complex demands from regulators, payers, and investors alike.

Why Mid-size Pharmaceutical Companies Need Epidemiology Consulting

Mid-size firms are the engine of innovation in life sciences. But they are being asked to deliver more, with less:

How BioEpiNet Adds Strategic Value

We plug into your existing Medical Affairs, RWE, or Clinical teams as your expert epidemiology partner:

1. Real-World Evidence Generation

We design and analyze studies that meet FDA/EMA standards for post-marketing surveillance, label expansion, and comparative effectiveness.

2. Systematic Literature Reviews (SLRs)

We deliver rapid, PRISMA-compliant literature reviews and evidence gap analyses to support market access and regulatory submissions.

3. Protocol & Statistical Analysis Plan (SAP) Development

We draft and refine protocols and SAPs to support registries, Phase IV studies, and investigator-led RWE programs.

4. Post-marketing Study Design & Safety Analytics

We support PSURs, signal detection, and RMPs with statistically sound observational methods.

5. Manuscript & Scientific Communication Support

From journal submissions to conference abstracts, we help transform your evidence into compelling, publication-ready outputs.

Real-World Examples of Our Impact

  • RWE study for label expansion in cardio-renal drug class
  • Meta-analysis of real-world safety data for CNS pipeline
  • Protocol & SAP development for oncology registry
  • SLR and value narrative for rare disease market access

Contact BioEpiNet for Epidemiology Consulting

If you’re preparing for your next submission, payer conversation, or evidence milestone, partner with BioEpiNet—your trusted epidemiology and biostatistics resource for pharma and biotech.

BioEpiNet
Based in Chicago — Serving clients nationwide
📞 (312) 709‑7336
🌐 www.bioepinet.com
📧 [email protected]
👉 Schedule a consultation