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Biotech as a Service
Accelerate your early Drug Development

aclrt.bio

You bring the asset. We move it forward.

We act as your embedded drug development organization.

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You plug your asset into a fully integrated and agile execution team that covers:

  

  • CMC & Manufacturing

  • Preclinical & Translational Development

  • Regulatory strategy & CTA‑enabling packages

  • Clinical development to Proof of Concept

  • Quality Assurance & GxP compliance

  • Program leadership, vendor governance and operations

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One team. One vision. One accountable partner.

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Designed for early oncology and immunology assets,
our cross-functional team replaces fragmented outsourcing

CMC & Manufacturing

CMC decisions made early
and deliberately, with
regulatory and clinical in mind

  • CMC strategy aligned with regulatory and clinical objectives

  • CDMO selection, contracting, and hands‑on governance

  • From DS to IMP

  • CTA‑enabling manufacturing packages and lifecycle planning

Preclinical Development

Assessment and consolidation of available preclinical package to support CTA readiness

  • Gap assessment aligned with regulatory expectations and clinical intent

  • Oversight of external partners and data quality

Translational Strategy

  • Translational framework connecting preclinical data to clinical hypotheses

  • Biomarker and MoA alignment with target patient populations

Early integration of translational endpoints into clinical development plans

Regulatory Strategy

Embedded from the start,
with decisions guided
by our aligned end goals

  • Global and innovative approach, exploring accelerated paths

  • Early identification and mitigation of risks, aligned with your long-term vision

Clinical Development

Programs designed and run
to answer the right questions, at the right time, with clear inflection points

  • Clinical strategy to Proof of Concept

  • Trial design aligned with TPP and translational hypotheses

  • CRO oversight, governance, and execution leadership

Program Management

  • End‑to‑end program leadership across all functions

  • Integrated planning, risk management, and decision cadence

  • Active orchestration of CDMOs and CROs

Single point of accountability, ensuring momentum,
alignment & execution discipline

  • Integrated scenario planning

  • Risk & time management

  • Active orchestration and oversight across all functions

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