Applied & specialist
Custom Studies
For the programme no standard guideline was written to cover
- Key capability
- Bespoke
- Listed methods
- 14
Overview
Custom Studies, in overview.
Discipline group
Applied & specialist
Capability groups
4
Custom Services exists to bridge the gaps in research and development — the studies that fall between guidelines, combine two disciplines, or need a model that does not yet exist.
Because the design work happens inside the same GLP quality system that runs our routine studies, a bespoke protocol carries the same defensibility as a standard one. That is the difference between a custom study and an improvised one.
Support runs across the whole product lifecycle: study design, assay development and validation, biomarker analysis, formulation development, biostatistics and regulatory support, through to data analysis and reporting.
Capabilities
Four capability groups. 14 listed methods.
Every method below runs inside the same quality system, against the same archive, with the same chain of custody. Study designs are assembled from this catalogue rather than improvised around it.
Design & development
4 methods
- Customised study design
- Assay development and validation
- Formulation development
- Customised animal models
Analysis
4 methods
- Biomarker analysis
- Genomic and proteomic analysis
- Pharmacogenomics
- Pharmacokinetic studies
Evaluation
3 methods
- Toxicology evaluations
- Efficacy assessments
- In vitro and in vivo studies
Reporting & regulatory
3 methods
- Data analysis and reporting
- Biostatistics
- Regulatory support
Under accreditation
What governs this work.
Custom Studies operates inside the quality system audited under the certifications listed here.
- OECD GLP
Good Laboratory Practice certification
OECD GLPNGCMA, Department of Science and Technology, Government of India
Compliance with OECD Principles of Good Laboratory Practice, the basis on which study reports are accepted across all OECD Mutual Acceptance of Data countries.
View the certificate
Runs alongside
Nothing here works alone.
Most programmes cross three or four divisions. On one campus, under one quality system, that crossing costs a corridor rather than a shipment.
- 01ToxicologySafety studies evaluating acute and longer-term effects, including toxicity, irritation and sensitisation, to support product safety and regulatory assessment
- 03ChemistryAnalytical chemistry that underwrites every other division's numbers
- 04MicrobiologySterility, endotoxin and environmental monitoring against ISO, USP and OECD methods