data mining methods enable the discovery of new or the repurposing of previously known pharmaceutical compounds in the development of treatments for new indications.
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Decentralized trials aim to improve patient access to trials by enabling patient follow-up from home or community care, increase the participation of more diverse populations, and enhancing data collection by combining the adoption of digital endpoints and telemedicine as applied to trials, decentralized trials aim
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Core Outcome Measures in Effectiveness Trials
Published by IRDiRC
Research and Drug DevelopmentClinical DevelopmentClinical Trial DesignEndpoint COMETOutcome MeasureEffectiveness TrialThe COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition, and are also suitable for use in clinical audit or research other than randomised trials.
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Clinical Research Networks
Published by IRDiRC
Research and Drug DevelopmentClinical DevelopmentNIHCRNClinical Trial ReadinessRare Disease Clinical Research NetworkCinical Trial DesignThe RDCRN is made up of multiple individual, Rare Disease Clinical Research Consortium (RDCRC) and a Data Management and Coordinating Center (DMCC). The RDCRCs are intended to advance the diagnosis, management, and treatment of rare diseases with a focus on clinical trial readiness
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BBMRI-ERIC – European research infrastructure for biobanking.
Published by IRDiRC
Research and Drug DevelopmentBiobankEuropean Union InfrastructureBBMRI-ERIC is a European research infrastructure for biobanking. We bring together all the main players from the biobanking field – researchers, biobankers, industry, and patients – to boost biomedical research
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FDA Qualification process – Drug Development Tools
Published by IRDiRC
Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEndpointBiomarkerAnimal ModelQualification ProcessDrug Development ToolCenter for Drug Evaluation and ResearchThis guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.
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Conditional and Time-limited Authorization of Regenerative Medical Products
Published by IRDiRC
Regulatory AffairsMarketing AuthorisationAdvanced Therapy ProcedureMHLW or PMDA Regenerative Medical ProductsPMD ActCTARPA regulatory framework for the approval of regenerative medical products to benefit the patients with unmet medical needs under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)
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Conditional Early Approval System for Medical Devices
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Regulatory AffairsEarly Access SupportMedical DeviceMHLW or PMDA RegulatoryPMDAConditional Early Approval SystemCEASDConditional Early Approval System is a system to put highly useful and effective medical devices for treating serious diseases into practical use as early as possible.
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Development of product specific bio-analytical assays
Published by IRDiRC
Research and Drug DevelopmentDrug DiscoveryBioassayBio-Analytical AssayMeasurement of drug concentrations in biological matrices (such as serum, plasma, blood, urine, and saliva) is an important aspect of drug development. These methods provide data to support the Safety and effectiveness of drugs, which may be needed to support applications for new drugs in regulatory pathways
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Certification for advanced therapy medicinal products
Published by IRDiRC
Regulatory AffairsEarly Access SupportAdvanced TherapyCertificationCommittee for Advanced TherapiesATMP CertificationThe European Medicines Agency’s Committee for Advanced Therapies (CAT) provides a certification procedure for advanced therapy medicinal products (ATMPs) under development by micro-, small- and medium-sized enterprises (SMEs) only
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