CDx & BIOPHARMA SERVICES
Offering a collaborative CDx partnership approach.
As an established IVD company, Randox Biosciences offers tailored development and testing solutions to support faster, more effective and safer development of new drugs.
We have a wide range of in-house capabilities, ranging from the selection and patenting of novel biomarkers; manufacture of bioreagents; production of single and multiplex RUO and IVD grade tests; quality control; provision of clinical laboratory services; regulatory expertise and worldwide distribution.
Why Partner with Randox?
Pharmaceutical and biotech companies are increasingly investing in the research and development of new therapies to address the world’s growing need for earlier and more effective patient treatment.
Randox Biosciences is dedicated to the improvement of personalised diagnostic, prognostic, and predictive assays. We aim to help Pharma Biotechs and CROs move away from a “one treatment fits all” approach and help get a better understanding of the complexity and variability of diseases and increase efficacy of treatment. A key element to realizing the potential for personalized medicine is companion diagnostic (CDx) development. Randox have key expertise in all elements of CDx and diagnostic development and offer a fully flexible partnership to accommodate your needs, providing you with tailored protein & molecular assays.
Randox Biosciences can be your CDx and biomarker assay development partner from early phase trials through to drug launch, addressing all assay requirements in the process, including development of raw materials and assays, verification and validation studies, clinical trial sample analysis, regulatory submissions and co-commercialisation.
Complete CDx Partner Approach
CDx Assay Formats
Randox Biosciences is focused on advancing precision medicine through high quality, flexible assay development. We can offer the full package of Diagnostic and CDx assay development with a range of technologies and platforms for use in clinical trials.
We invite researchers to design their specific multiplex custom array, containing selected biomarkers, ensuring maximum output from a limited sample supply. Our proprietary multiplex biochip array technology can be used in early exploratory biomarker stages and can be brought through to IVD/CDx grade.
CDx Drug and Diagnostic Development Process
Development of Raw Materials
- Extensive portfolio of over 900 products for R&D applications
- Products manufactured under ISO13485 accreditation including mAbs, PAS, HRPs, sdAbs, scFvs
- Capable of custom antibody and protein development
Assay Development
- Randox offer a range of technologies and platforms for use in clinical trials
- Our Biochip technology can be used in early exploratory biomarker stages and brought through to IVD/ CDx grade.
- Comprehensive OEM capabilities for developing assays on any platform.
- Assays developed under full design control and ISO13485 accreditation
Sample Testing
- ISO17025, ISO15189 and GCP accredited laboratories located throughout the UK, Ireland and USA.
- Randox Clinical Laboratory Services (RCLS) can be used to meet bespoke sample analysis needs.
- Strong global network with 3rd party laboratories to ensure clinical trial requirements are met across the world.
Verification & Validation
- Performance of in depth multi lot verifications following CLSI guidelines to ensure full performance requirements are met
- Provide support for regulatory submissions and approvals
- Validation of assay performance and reproducibility across multiple sites
Regulatory Submission
- Experienced in-house regulatory teams provide FULL regulatory support preparing IVD/ CDx submissions and applications for approval.
- Regulatory and Development teams work closely in collaboration with the pharma partner to ensure a timely submission while keeping in line with country specific requirements
- 954 licences across the globe and over 3800 licensed products
Commercialization
- Pre and Post launch support with laboratory, clinician, patient and KOL engagement.
- Strong global laboratory and distribution networks, in house sales and marketing teams, with operations in over 145 countries.
- Capable of manufacturing customised sample collection kits under full design control
Randox Platforms