iClinDev
Biotech & Venture Consulting

iClinDev Biotech & Venture ConsultingiClinDev Biotech & Venture ConsultingiClinDev Biotech & Venture Consulting

iClinDev
Biotech & Venture Consulting

iClinDev Biotech & Venture ConsultingiClinDev Biotech & Venture ConsultingiClinDev Biotech & Venture Consulting
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Driven by Data and Evidence

Driven by Data and EvidenceDriven by Data and EvidenceDriven by Data and Evidence

Consulting in All Areas of Clinical Development for Biotech/Pharma Industry and Venture/Hedge Funds Investing in Biotech

What We Do

Biotech/Pharma Industry Consulting

Venture Capital/Hedge Fund Advising

Venture Capital/Hedge Fund Advising

  • Independent medical monitoring of clinical trials, including unblinded data review
  • Design of clinical studies meeting regulatory definition of AWC ("adequate and well controlled") study to demonstrate efficacy and safety
  • Complex trial designs, including basket, umbrella, adaptive, SMART/SPCD, Bayesian/BOIN, multi-part, and platform trials
  • Study Protocols, IBs, ICFs
  • IRB/IEC submissions
  • Safety Surveillance/Management Plans
  • CSRs
  • PIPs/PSPs
  • TPPs
  • CDPs, IDPs
  • Primary/secondary endpoints, biomarker/surrogate endpoints, COAs/eCOAs, imaging charters, natural history and external controls, prognostic and predictive factors
  • Use of RWD and RWE, including digitals/wearables
  • Patient registries (safety/efficacy)
  • Pre-approval/Expanded Access Programs
  • INDs (COs, GIPs)
  • NDAs (eCTD Modules 1, 2, and 5, including CSEs/ISEs and CSSs/ISSs)
  • Clinical input for key Regulatory Agency interactions: e.g., Clinical Hold/Type A, EoP/Type B, WRO/Type C, START/Type D (pilot by FDA), INTERACT FDA meetings
  • Advanced Regulatory Designations (including Orphan Drug, Rare Pediatric Disease, Fast Track, Breakthrough, RMAT, ATMP, etc)
  • Safety/Efficacy White Papers, Clinical Impact Assessments
  • DSURs, PBRERs (PSURs), IND Annual Reports (PADERs)
  • RMPs, REMSs
  • SAE narratives, Company analyses for SUSARs
  • DSMB/Data Monitoring Committee charters and meeting organization
  • Advisory Boards set up, KOL ongoing engagement (e.g., establishment of standing Scientific Advisory Boards through networking with leading KOLs) 
  • Portfolio prioritization and clinical development program review

Venture Capital/Hedge Fund Advising

Venture Capital/Hedge Fund Advising

Venture Capital/Hedge Fund Advising

  • Comprehensive analysis of available data to inform clinical/medical aspects of due diligence evaluations
  • Preclinical/clinical data analysis for business development/investment evaluations (e.g., IND readiness)
  • MoA analysis with competitive landscape assessment
  • Compound viability analysis from FIH/FIP (safety) through PoC (efficacy)
  • Regulatory probability of success (approval of a marketing application: NDA/BLA, MAA)
  • Phase-specific CSI (Compound Success Index per each Phase of Development): data and evidence-driven model providing probability of success in a given phase of clinical development

Past Experience and Select Areas of Expertise

Our Experience and Expertise

  • Therapeutic areas of expertise: rare diseases (e.g., mucopolysaccharidoses, glycogen storage diseases, lipid storage disorders), neuro-degenerative/-muscular diseases, infectious diseases, virology, GI/hepatology, rheumatology, dermatology, immunology, immuno-oncology
  • Compounds/NMEs: small molecules, biologics/mAbs, gene therapies, cell therapies, drug/device combinations
  • Development Phases: Translational: 1 & 1b; PoC: 2a & 2b; Pivotal/Registrational: 3 & 3b; Post-approval: 4 & PASS/PMRs

Our Approach

  • We provide turn-key comprehensive "A-to-Z" consulting in all areas of Clinical Development for Biotech/Pharma companies and Venture Capital/Hedge Funds investing in biotech
  • All our work is deeply rooted in the principle that analyses and decisions should be data-driven and based on existing and emerging evidence
  • We use state-of-the-art analysis and decision making tools for in-depth objective evaluations


Our Key Advantages

  • Providing Comprehensive and Global Clinical Development Consulting
  • Track Record of Successful Biotech/Pharma Clinical Development
  • In-depth Understanding of Your Unique Needs to Offer Highly Specialized and Customized Consulting Services
  • Around the Clock Availability for Any Emerging/Urgent Issue or Need
  • Dedicated to Your Success: We Succeed Only When You Achieve Your Goals and Objectives
  • High Caliber Experts (Licensed and Board Certified Physician-Scientists) with 20+ Years of Combined Biotech/Pharma and Regulatory (FDA, CDC) Experience

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iClinDev Biotech & Venture Consulting

Chicago, Illinois, United States

+1 (847) 505 - 3010

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