CDMO / R&D
CDMO product development coordination
Coordinating formulation, analytical and scale-up work across a CDMO and a separate testing laboratory.
Illustrative use caseCapability
CRO / Contract Research
Research and development studies coordinated with contract research organisations, with DGXPComplianceLab managing scope, data and documentation.
What we do
Contract research organisations run studies that most pharmaceutical companies do not keep in-house. The value of coordination lies in a clear study scope, the right organisation, and a data package that answers the development question.
Only capabilities available through qualified partners are offered. Each request is assessed for scope, regulatory context (GLP/GCP where applicable) and partner availability before commitment.
Where it fits in the pharmaceutical lifecycle
Typical activities
Each activity shows who performs it. We do not claim facilities we do not own.
DGXP-led Led by the DGXPComplianceLab team Partner-coordinated Performed by a qualified partner, coordinated by us
Research support
DGXP-ledStudy concept, design review and scientific rationale.
Development studies
Partner-coordinatedStudies that support formulation and process decisions.
Analytical research
Partner-coordinatedCharacterisation and investigative analytical work.
Clinical research support
Partner-coordinatedCoordination support around clinical study documentation and vendors.
Bioanalytical support
Partner-coordinatedWhere applicable, through partner laboratories with appropriate compliance.
Data and documentation support
DGXP-ledProtocol and report review, data integrity checks, archiving expectations.
Project coordination
DGXP-ledTimelines, communications, deliverables and change management.
Contract research coordination
- 1Research question
- 2Study scope
- 3CRO identification
- 4Protocol review
- 5Study conduct
- 6Data review
- 7Report
- 8Decision
Technologies and processes
- GLP / GCP principles
- Study protocols & reports
- Electronic data capture
- Bioanalytical method validation (ICH M10)
- Data integrity (ALCOA+)
Example projects
Illustrative use cases showing how this capability is typically applied.
Laboratory / Quality
Contract laboratory testing programme
Setting up release and stability testing at a contract laboratory for a new product.
Illustrative use case
Digital / AI / Laboratory
Pharmaceutical data intelligence
Bringing batch, laboratory and quality data together for trending and product review.
Illustrative use caseOur project execution model
Every engagement follows the same eight steps, scaled to the size and risk of the project.
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01
Understand
Understand business and technical requirements.
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02
Assess
Assess scientific, technical, regulatory and operational requirements.
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03
Design
Design the appropriate solution.
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04
Identify
Identify appropriate internal and external capabilities and partners.
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05
Execute
Coordinate and execute the project.
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06
Verify
Test, verify, qualify or validate where applicable.
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07
Document
Create technical, quality and regulatory documentation.
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08
Improve
Monitor, optimise and continuously improve.
Related services
Contract Laboratory
Analytical testing, method work and stability programmes arranged with contract laboratories, with clear lines between …
Research & Development
Structured research and development support that moves a product idea through pre-formulation, formulation, analytical …
Regulatory & Quality
GxP compliance, validation and documentation practices that make pharmaceutical work traceable, reviewable and inspecti…
Frequently asked questions
Are you a CRO?
No. Studies are run by qualified contract research organisations. We scope, coordinate and review the work.
Which study types can you support?
It depends on partner availability for the specific study. Send the study need and we will confirm what can be supported.
How is data integrity handled?
Protocols, raw data expectations and reporting are reviewed against ALCOA+ principles, and archiving responsibilities are agreed up front.
Discuss a cro requirement
Share the product, stage and timeline. Capability is confirmed after technical assessment and partner availability.