01Communication
One project lead
One accountable project lead coordinates work across specialist organizations, manages stage deliverables and client communication, and supports decisions at each stage.
How we work
Clear communication, connected execution
One accountable project lead directs cross-functional execution toward your agreed objectives, with clearly defined scientific, technical, quality and project management responsibilities.
Together, we establish the Project Charter, defining the baseline, success criteria and initial work package. The Project Master Plan governs execution, while the Delivery Evidence Chain supports stage review, acceptance and decisions on what comes next.
Working together
What stays clear throughout the project
02Scope
An agreed path through the work
The Project Charter defines the objectives, baseline, success criteria and initial work package, together with responsibilities, stage gates and change control.
03Evidence
Reviewable outputs at each stage
Each stage connects its deliverables to supporting records, so you can review the evidence and decide whether to proceed, request additional work, pause or accept the deliverables.
Project coordination does not replace independent quality oversight, radiation-safety responsibilities or the statutory responsibilities of manufacturing and clinical organizations.
Across the project pathway
Connected work, distinct delivery responsibilities
Theranostics links diagnostic imaging, patient stratification, targeted radionuclide therapy, and response and safety assessment through a single molecular target. One Project Master Plan aligns radionuclide supply, product quality, clinical milestones, radiation safety and responsibilities across participating organizations.
Radionuclides and sources
Current Direct deliveryHUAHE manages the agreed supply of Lu-177, Ac-225 and other radionuclides, coordinating orders, documentation and compliant delivery.
Discovery and early-stage research
Current Direct deliveryHUAHE delivers agreed early-stage research for universities, research organizations and biotech clients, combining candidate assessment, radiolabeling, analytical characterization and small-animal imaging to generate early-stage evidence.
Process development and transfer
Current Integrated deliveryHUAHE integrates process development, analytical method development and related chemistry, manufacturing and controls (CMC) work, linking the resulting technical knowledge to site adaptation and acceptance by the receiving site.
Manufacturing and supply
Current Integrated deliveryHUAHE integrates manufacturing scheduling, documentation review, packaging and transport for clinical and commercial supply. Qualified, licensed manufacturers retain responsibility for manufacturing, testing and batch release.
Clinical translation and application
Specialist collaborationHUAHE works with hospitals and clinical centers to connect clinical needs with investigator-initiated trials (IITs), clinical validation, PET/SPECT, dosimetry and efficacy feedback, and clinical implementation planning. These institutions carry out the specialist clinical work.
Materials, data and quality records move forward with the project; imaging, dosimetry, efficacy and safety evidence informs subsequent decisions. HUAHE manages project interfaces, evidence continuity and confirmation of stage deliverables; specialist organizations retain their assigned responsibilities.
Connected expertise
One point of contact, clear responsibilities
Client contact
Project lead
Directs execution of the Project Master Plan, managing scope, resources, schedule, risks, change control, client communication and delivery confirmation.
One accountable point of contact
01
Scientific team
Designs the research approach, interprets results and provides scientific judgments for stage review.
Study design · Evidence interpretation02
Technical team
Connects radiolabeling, process development and technology transfer through the agreed technical work packages.
Technical execution · Site implementation03
Quality function
Provides independent quality oversight and reviews data and records against applicable requirements.
Independent oversight · Record reviewBefore launch, both parties confirm their project leads and the first work package. Cross-functional resources, an execution plan, milestones and arrangements for reviewing stage deliverables are put in place for the agreed scope.
Project operating model
One plan governs execution, one evidence chain supports acceptance
Execution control
Project Master Plan
Governs execution against agreed objectives, responsibilities, milestones and change controls.
- Objectives, scope and responsibilities
- Resources, timeline and stage gates
- Risks and change control
GuidesCoordinated execution
Delivery record
Delivery Evidence Chain
Makes each stage’s results a reviewable, usable input for the next.
- Protocols and source data
- Technical documents and quality records
- Delivery confirmations
SupportsReview and acceptance
Review at every stage
Progress is measured by reviewable outputs
Define the work
Define the project baseline, success criteria, responsibilities and first work package before execution begins.
Input
Confidentiality arrangements, contacts, current-stage evidence, objectives, quality requirements, delivery window and constraints
Output
Project Charter, Project Master Plan and acceptance criteria
This workflow presents a general operating model. Stages, records, decision rights and acceptance steps are tailored to each engagement and defined in the applicable project documents.
Connect with HUAHE
Start with your current stage
Share your organization, the work completed so far and the outcome you need next. A non-confidential overview is enough to begin.