DrugDevX
Services

Oncology clinical-development services tailored to your needs.

Eighteen services in three areas, from fractional CMO leadership and clinical data review to trial oversight and carefully scoped AI work. Start from your stage, your question or the area that fits.

What the evidence looks like at each stage of oncology developmentFive panels along a development line: dose-finding curves before first-in-human, a response waterfall plot in Phase 1 to 2, time-to-event curves in Phase 3, a benefit-risk forest plot at filing and real-world evidence over the lifecycle. Schematic illustration; it contains no data.The evidence changes at every stageDose-findingResponseTime-to-eventBenefit–riskReal-worldPre-INDPhase 1–2Phase 3FilingLifecycleSchematic illustration. No data are shown.
Featured engagements

Leadership when you need it. Clarity when the data arrive.

Two engagements that bring several of our capabilities together around a single outcome.

Fractional CMO Services

Senior medical leadership, scaled to your stage.

An experienced oncology clinician takes responsibility for clinical direction on an agreed part-time basis, with defined decision rights and a clear mandate.

  • Development strategyPlan, sequence, dose and endpoint decisions
  • GovernanceDecision rights, medical oversight and escalation
  • Team and providersDirection of the CRO, operations, data and monitoring
  • Board and executivesClinical content for boards, investors and partners
  • MilestonesFocused leadership at readouts, filings and transactions
Read about Fractional CMO Services
Clinical data review & communication

From first patient profile to final datacut.

Physician-level review of oncology data, carried through interpretation and benefit–risk assessment into the narrative each audience needs.

  • Patient-level reviewChronology, exposure, safety and response, patient by patient
  • Efficacy and safetyStudy-level interpretation against the plan and the disease context
  • Benefit–riskA structured judgment with the uncertainty stated
  • Narrative and presentationMessages, figures and briefings for leadership, regulators and scientists
Read about clinical data review
Explore by area

Three areas. Choose a stage to narrow the view.

The five bars beside each service run from pre-IND on the left to post-approval on the right and mark where it is most often relevant. Filter by stage, or move through the areas.

Development stage
Strategy & Evidence

Fractional CMO Services

Senior medical and clinical-development leadership for oncology companies that need chief-medical-officer judgment now, but not yet a full-time executive, or that need to extend a leadership team through a critical stretch.

Best for
Emerging oncology sponsors, boards and CEOs
You receive
A written assessment of the development plan and a prioritized decision agenda; Clinical positions and decision memoranda on the questions we lead
Stages
Pre-IND / FIH to Registration
Formats
Part-time retainer or milestone project
Read the full service
Execution & Oversight

First-in-human & first-trial readiness

A clinically anchored readiness review for the move from preclinical development into a first human study.

Best for
Preclinical and early clinical biotech teams
You receive
A clinical readiness gap assessment; An owner-and-dependency roadmap to the next milestone
Stages
Pre-IND / FIH
Formats
Clinical readiness assessment
Read the full service
Data, AI & Capability

Clinical data review, interpretation & communication strategy

Physician-level review of oncology clinical data, carried from the individual patient to the study-level conclusion, and then into the narrative, figures and presentations that leadership, regulators and the scientific community will see.

Best for
Sponsors approaching a readout, a regulatory discussion or a partnering decision
You receive
A medical-review plan, review-listing specifications and an issue log ranked by clinical consequence; A written interpretation memorandum covering efficacy, safety, exposure and dose findings, with their limitations
Stages
Phase 1–2 to Post-approval
Formats
Review plan, data-cut project or ongoing support
Read the full service
Start from your situation

What is in front of you right now?

Most questions touch more than one service. These are common starting points.

We are deciding where to take the programIndication, sequence, dose and what to prove first.

Development strategyFractional CMO ServicesCompetitive intelligence

A protocol or data-collection design is about to be committedTest the design before sites and systems depend on it.

Protocol development & reviewCRF design & data collectionFirst-in-human readiness

A study is running and something is not workingEnrollment, consistency, vendor delivery or an issue no one owns.

Trial execution & issuesCRO & sponsor oversightStudy start-up & sites

We have data and need to know what it meansInterpret it, assess benefit–risk and present it to the right audience.

Clinical data review & communicationRegulatory supportDocuments & safety narratives

We are assessing an asset, a partner or a vendorA clinical view of the evidence, the landscape or the workflow.

Asset diligenceCompetitive intelligenceeClinical vendor selection

We want to use AI, or build review capabilityA defined use, a real test and a team that can review consistently.

AI workflow advisoryClinical AI evaluationTeam simulations & training
Ways to work together

Scope follows the question.

Services can be combined within one engagement. We agree on deliverables, responsibilities and the specialists involved at the start.

A defined document or decision

Independent review

A protocol, an asset, a vendor, a data cut or a briefing package. Materials, deliverables and turnaround are agreed up front.

A bounded piece of work

Milestone project

Focused work around a development inflection point, combining services where the question needs them.

Scheduled senior input

Fractional or retained support

Regular clinical leadership or advice over a period, from monthly strategic input to a Fractional CMO mandate.

Start a conversation

Tell us about the decision in front of you.

A short, nonconfidential outline is enough: the development stage, the question and the timing. We will reply about fit, expertise and next steps.

Email DrugDevX Prepare an inquiry

Email links open your email application. Nothing is sent until you press send. Please do not include patient information or confidential study materials in a first message.

  1. 01
    Outline the needThe decision, the stage of the program and the timing.
  2. 02
    Establish fitExpertise, availability, relevant interests and information requirements.
  3. 03
    Agree the scopeDeliverables, responsibilities and commercial terms before work begins.