iFeed combines weekly regulatory intelligence, hands-on delivery support and the ClinAssure platform in development to help BA, BE, clinical-trial and QMS teams turn changing expectations into clear action.
W31 opens with USP and EDQM publishing a stakeholder-forum outcome that deepens pharmacopoeial harmonisation and regulatory reliance — compendial convergence as quiet infrastructure — alongside an early, disciplined-to-read overall-survival readout from Faron's Phase 1/2 BEXMAB trial in higher-risk MDS. An opening baseline traced to primary sources; the week is still unfolding.
Read Week 31 signal ->Study set-up · ethics · regulatory
Protocol · method development · training
Data capture · clinical operations · laboratories
Quality · audit · CAPA
Reporting · optimisation · learning
iFeed supports organisations working in bioanalytical, bioequivalence, clinical trials and quality. These are the areas where data integrity and quality management determine whether a submission holds up to inspection.
We work in three ways: regulatory intelligence that tracks what is changing across the FDA, EMA, MHRA, ICH and the EDQM; ClinAssure, a controlled workspace in development; and delivery services that put experienced people alongside your team.
Eight years across CRO and sponsor environments in bioanalytical, bioequivalence and clinical trials, focused on operations, quality and execution.
LinkedIn ↗BA, BE, clinical trials and QMS are connected in practice. iFeed brings them together as one readiness view rather than four disconnected conversations.
Methods, sample lifecycle, audit trails and reporting expectations mapped into practical readiness work.
Sample · Method · DataDemonstrating that a generic performs the same as the reference product, across clinical conduct, PK and statistical evaluation.
PK · ISR · StatisticsStudy conduct, essential documents, site oversight and close-out, aligned to evolving GCP expectations.
Protocol · Conduct · CSRQuality management, document control, CAPA and inspection readiness across every domain.
QMS · CAPA · AuditEach week we review primary sources and translate the most important changes into what they mean and what teams should check next.
From making systems inspection-ready to running the study, engaged as a project or as an extension of your team.
Current-state review, gap assessment, data-integrity remediation and CSV planning so systems and records are ready before an audit exposes the gap.
DI · CSV · 21 CFR Part 11Implementation planning, validation planning and operating support for ClinAssure as it develops across bioanalytical, bioequivalence and clinical-trial workflows.
Deploy · Validate · OperateBuilding and running the quality system: SOPs, CAPA, document control, training and audit management, kept current with changing regulation.
SOP · CAPA · EDMSExperienced people alongside your team to deliver study operations: method validation, clinical operations, PK and statistical analysis, and submission-ready reporting.
Method · Ops · SubmissionBioanalytical, bioequivalence, clinical-trial and quality work: operations, quality and execution, delivered as a project or an extension of your team.
ClinAssure is our controlled workspace in development, designed to connect QMS, document control, training, evidence, submission readiness and audit readiness so teams can move from scattered work to clear, inspectable deliverables.