USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints
EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
SFDA MD Guidance: Requirements for Clinical Trials of Medical Device
USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
USFDA Guidance: Multiple Endpoints in Clinical Trials & Gene Therapy for Neurodegenerative Diseases
EMA- New Guidance on Complex Clinical Trials
Guidance for Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
UK Guidance on Clinical Trials: How to Apply for Authorization
Finland adopts New Act on Clinical Trials Legislation (FIMEA)
Clinical Trials Information System (CTIS) to go-live in 6 Months – EMA
Clinical trials: Apply for authorisation in UK – MHRA
Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA