Accelerating Clinical Trials
Expert Clinical Operational Leadership

NexGen ClinOps Consulting delivers over 20 years of global experience
and expertise in clinical research.
Director-level consulting for biopharma, biotech, and CROs.
Leverage over 12 years of global clinical program and project management, service
provider oversight and regulatory success to optimize your trials.
Learn more

Global Expertise

With over 20 years of global clinical research experience, we offer expert clinical operations and project management consulting services. We combine operational precision with scientific rigor to ensure successful clinical trials, from First-In-Human to pivotal and Phase IV studies, from a single-site to large, complex and multi-country programs.

Our Services

NexGen ClinOps Consulting offers hands-on expertise across every phase

of clinical trial execution, from start-up to closeout.

NexGen ClinOps Consulting also offers targeted SWAT and Rescue services

for studies in distress-helping to resolve site performance issues, enrollment delays,

service provider misalignment, compliance, risks, and more.

  • Project Management Excellence

    • Clinical development planning and execution
    • Budget development, forecasting, tracking, and risk mitigation
    • Timeline management and milestone delivery

  • Full Clinical Operations Oversight

    • End-to-end study lifecycle management (Phases I–IV, FIH, pediatric, vaccine trials)
    • Day-to-day operational leadership and team coordination
    • Study design input and protocol review support

  • Regulatory & Study Start-Up Support

    • Regulatory submission, planning and document review
    • Country/site feasibility, selection, and activation
    • Global launch support (NA & LATAM, EMEA, APAC, CEE, and Africa)

  • Monitoring Strategy & Execution

    • Risk-based monitoring, plans, documents and oversight
    • Monitoring and data flow oversight; query resolution support
    • Service providers alignment on monitoring strategy and reporting

  • Medical & Scientific Support

    • Protocol and Protocol Amendments development support
    • Safety oversight collaboration and clinical data review
    • Deviation tracking, and trending analysis for operational oversight and improvements

  • Audit/Inspection Readiness & GCP Compliance

    • Sponsor and site audit/inspection readiness; TMF management
    • SOP gap assessments; CAPA development & oversight
    • Continuous quality control & risk management

Why choose us

We combine clinical rigor with real-world operational leadership: your studies run faster, cleaner, and smarter

  • 20+ Years

    of Global Hands-On ClinOps Experience

    • From CRA to Director-level leadership- we bring deep operational insight across every phase of clinical trials.
    • We bring expert-level leadership and full-lifecycle expertise across global clinical trials, from FIH to Phase IV.

  • Strategic Execution, Not Just Oversight

    • We don’t just “run the study”- we align your clinical operations with strategic goals, ensuring compliance, quality, and delivery.
    • We align operational delivery with your program’s bigger picture- driving timelines, compliance, and trial success.

  • SWAT & Rescue Support

    • Struggling study? We specialize in rapid-response interventions for stalled or at-risk clinical trials.
    • Facing delays or under-performance? Our SWAT-style support rapidly identifies root causes and gets your trials back on track.

  • Therapeutic Breadth & Global Depth

    • Deep experience across a variety of therapeutic areas: cell therapy, oncology, gastro-enterology, auto-immune disorders, cardiology, respiratory, endocrinology, vaccines, infectious diseases, and more.
    • Spanning all regions globally and emerging markets.

  • Flexible, Sponsor-Centric Solutions

    • We adapt to your trial’s needs- whether you need full oversight, temporary fill-in, or a specialized operations partner.
    • We tailor solutions to your needs- offering plug-in support, full study oversight, or anything in between.

  • CRO & Service Provider Oversight

    • We act as your eyes and ears—ensuring CRO and/or service providers deliver on expectations with proactive communication, quality tracking, and accountability at every step.
    • We ensure CRO and service providers stay aligned, accountable, and on track.

About the Founder


Petro Savchenko, MD

Founder & ClinOps Director

Dr. Petro Savchenko is a Clinical Operations & Project Management Expert with over 20 years of Global Clinical Research Experience.

As a medical doctor with deep clinical operational expertise, Petro helps biopharma and CRO clients execute complex phase I-IV clinical trials.

He led clinical programs in Oncology & Immuno-Oncology (CAR-T, LBCL, FL, CD70, etc.), Gastroenterology (Crohn’s, UC, IBD), Cardiology, Endocrinology, Rheumatology, Psychiatry, Neurology, Infectious Diseases, and more.

Key strengths:

  • Full project management (budgets, resources, timelines, risk management).
  • Servise Providers & CRO oversight.
  • GCP compliance and audit/inspection readiness; TMF management.
  • Data-driven medical and operational insights.
  • Hands-on leadership for global, multi-country programs.

Dr. Savchenko passionate about bridging operational strategy and scientific rigor- delivering studies that are on-time, on-budget, and CGP/regulatory compliant.

Explore our success stories

Review some of our case studies to see how we’ve helped clients achieve their clinical trial goals and overcome challenges.

First-In-Human Trial Rescue

Client: Emerging Biotech, US-based
Challenge: FIH study was delayed due to vendor misalignment and protocol deviation risks.
Our Solution:
  • Stepped in as interim Clinical Operations Lead.
  • Rebuilt the study timeline, re-trained site staff, and aligned CRO.
  • Established a robust risk-based monitoring (RBM) plan.
Outcome:
  • Study restarted in 3 weeks.
  • First patient dosed ahead of the revised schedule.
  • No major findings during FDA pre-IND inspection.

Phase II Program Stabilization

Client: Mid-size US Sponsor
Challenge: Phase II oncology study across 7 countries was under-enrolling and facing frequent protocol amendments.
Our Solution:
  • Conducted feasibility reassessment and added 5 high-performing sites.
  • Streamlined CRO communication and handled amendment coordination.
  • Implemented weekly data and enrollment analytics dashboards.
Outcome:
  • Enrollment rate increased by 70%.
  • Protocol amendment finalized without delays.
  • Study locked on time and within budget.

Phase III Pivotal Study Oversight

Client: Large Global Biopharma
Challenge: Needed high-level operational oversight for a pivotal Phase III IBD trial in 30+ countries.
Our Solution:
  • Provided strategic program oversight and vendor governance
  • Coordinated with global medical team on safety reporting and IDMC
  • Led global site activation and maintained regulatory compliance
Outcome:
  • Study enrolled 2600 patients within target window.
  • NDA submission accepted by FDA with zero data integrity concerns.
  • Drug has been succesfuly marketed.
Hear from our clients
  • NexGen ClinOps Consulting's expertise significantly improved the efficiency of our Phase III trial.
    A. Johnson
    Senior Project Manager, Mid-size Biotech Company
  • We were impressed by NexGen ClinOps Consulting's deep understanding of regulatory requirements. Their guidance ensured our study met all milestones and deadlines without any compliance issues.
    B. Landman
    Director of Clinical Operations, Pharma Company
  • The NextGen ClinOps Consulting collaborative approach and clear communication were invaluable for our trial success.
    C. Davis
    Clinical Research Associate, Small Biotech Company
  • Their budget management expertise helped us stay within our allocated funds, while still achieving exceptional results.
    D. Williams
    VP of Clinical Development, Biopharma Company

Let's collaborate!


Are you looking for a Director-level consultant to boost

and elevate your clinical trial?

Contact us today and discover how we can help.

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