Orbis Clinical的动态

Exciting news for BJ!

Stay informed with this week’s Life Sciences Regulatory updates. Follow Freyr Regulatory Roundup. https://lnkd.in/gctsyvP5 ? #HealthAuthority #LifeSciences #RegulatoryUpdates #FreyrRegulatoryRoundup #FreyrSolutions

?? STUDY DATA BY FDA ? ? Are you planning to send a submission to the FDA? ? ? Will this submission contain study data? ? ? If the answer to these 2 questions has been yes, this information may be of your interest! ? ? The #FDA implemented the Technical Rejection Criteria (#TRC) for Study Data by #CDER and #CBER. ? ? At ASPHALION, we are experts and can give you #support in all your #RegulatoryOperations #Submissions. ? ?? Contact us: [email protected] ? ?? Have a look at the brochure for an overview in detail ? ? #Data #DataManagement #ClinicalTrials #TRC #Submissions #eSubmission #ElectronicSubmission #eSubmissions #study #ectd #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience ? https://lnkd.in/e-z4hvrb

The validation process at Techorizon follows a logical flow starting with the general planning, to the definition of specifications, the planning and execution of tests and finally, the validation report. The validation strategy is based on risk analysis and testing of all standard functions during the operational qualification phase. All issues that can be addressed during a clinical project are covered. If you need a fully configured and validated system for clinical research, contact Techorizon! https://lnkd.in/eVjZs5e #techorizon #technology #ecrf #lifesciences #edc #LifeSciences #clinicaltrials #clinicalresearch #healthcare #healthtech #validationprocess

Great piece by Professor Molloy looking at the opportunities and challenges for the UK's life sciences sector. Some takeaways: - More funding opportunities needed, particularly for early-stage SMEs - Medicine discovery clusters are vital, especially when lab space and equipment are harder to access - The development of more novel therapeutics means that specialised skills and talent are needed to deliver on the promise of innovative medicines

Delays in clinical trials might occur because of multiple reasons. But lack of top clinical talent is a major cause behind trial delays. But you can steer clear from these issues by partnering with experts like us. We have the best-in-class #biometrics team with the right capabilities to be your cost-effective FSP, and onshore/offshore partner. Learn more about our innovative services here: https://bit.ly/3SHFcgX #ClinicalTrials #LifeSciences #ClinicalResearch?

Demand for Advanced Therapy Medical Products (ATMPs)?continues to grow, with Northern Ireland boasting a strong cluster of companies focused on areas including biomarker identification, digital biomarker development, and assay validation.? ? To meet demand, manufacturers are increasingly turning to Single Use Technology (SUT) during clinical stages to aid production. In 2024, we predict an uptick in demand for engineering professionals, as employers adapt operations to reflect market demands. Want to know more about latest life sciences labour market trends? Download a copy of our Forward Focus report >> https://lnkd.in/et_JVdiy? ? #cpl #northernireland

1. Live eLearning Weekend Sessions with Signal Detection Software Training 2. LMS Access - PPTs, Notes, Modules, Session Recordings 3. Certification - Cliniminds USA ACCRE Accredited Duration - 2 Months /?30 Hours Batch Commencement Sunday 14th July 2024 #Pharmacovigilance #DrugSafety #PatientSafety #AdverseEvents #MedicalMonitoring #ClinicalTrials #RiskManagement #DrugRegulation #HealthCare #MedSafety #Pharma #RegulatoryAffairs #SafetyMonitoring #Pharmaceuticals #DrugDevelopment #Pharmacology #SafetyScience #Vigilance #MedicationSafety #ClinicalResearch #SignalDetection #Pharmacovigilance #DrugSafety #AdverseEventReporting #PatientSafety #RiskManagement #SafetyMonitoring #DataAnalysis #MedicalMonitoring #Pharma #ClinicalTrials #Pharmacology #RegulatoryAffairs #Healthcare #SafetyScience #AdverseEvents #DrugSurveillance

Signal Evaluation & Management Webinar by Cliniminds India #SignalDetection #Pharmacovigilance #DrugSafety #AdverseEventReporting #RiskManagement #SafetySurveillance #ClinicalSafety #SafetySignalDetection #DrugMonitoring #SafetyScience #PharmaSafety #MedicalSurveillance #AdverseDrugReactions #SafetyDataAnalysis #PatientSafety #HealthcareSafety #VigilanceReporting #SafetyAssessment #SafetyMonitoring #PharmacovigilanceTraining

Report card: 1) a. In 2023, as an industry colleague and a facilitator, I offered assistance to place 28 SMEs in Biopharma. I am not a recruiter. The hiring managers trusted my opinion to recommend associates for their needed talents. The recruits received my humble advise to expedite their search. 1) b. In 2024: So far 12 people have benefited from this facilitation. 2) In 2023 & so far 24: Clinical consults and advise to seek centers and treating MDs to 39 international indigenous/low income patients, with patients’ referral and more. All in clinical oncology, inflammatory, as well as, rare disease cases. Free of charge. Pay it forward. Help me to do more. Let’s work together, as possible.