Digital Reimagination of Clinical Trials

Digital technologies help transform and reposition businesses around the globe. The life sciences industry has also felt their impact, and numerous attempts have been made over the last few years to pilot the use of these technologies in clinical trials. Given the common challenges of on-time patient recruitment, retention, adherence, and stringent clinical trial  execution timelines faced by life sciences …

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Managing Regulatory Compliance in the Pharmaceutical Industry

Changes in regulation, alongside the introduction of stringent anti-corruption legislation, are forcing pharmaceutical companies to renew their focus on compliance. Globally, pharma organizations have to embrace a holistic approach. This involves aligning complex and disparate risks and regulatory compliance activities to the overall corporate strategy. The Increased Risks in Regulatory Compliance The pharmaceutical industry is coming under increased scrutiny across …

Tata Consultancy Services whitepaper

The Clinical Trial Supplies Control Tower: Gain End to End Visibility for your Clinical Supplies

Clinical trials are getting more global, complex, larger and focused, with CROs facing added pressure to complete them faster. Dynamic market changes demonstrate a need for more collaborative IT solutions that can address new risks across the clinical trials supply chain. The control tower can be leveraged to make these clinical supply chains more responsive, beyond time zone, geography and …

Embracing big data and emerging technologies in drug safety

Which new approaches are pharma companies taking to exploit opportunities offered by big data? We’ll be answering this question and many more as we discuss big data and related innovative technologies at World Drug Safety Congress Europe. Hear from a plethora of thought leaders who will be sharing real life examples of how to develop big data programmes and social media …

Raj More, Chief Architect & CEO of RxLogix Corporation to present at the Drug Safety Europe Congress this September in Berlin

Raj, a senior Relsys employee, started with Relsys in 1997, and has been associated with Argus Safety from its v1.0.  He was VP of Services & Strategy at Relsys when Relsys was acquired by Oracle. Raj has personally implemented Argus Safety in more than 50 companies both large and small. Simply put, Raj is synonymous with Argus, the two are intertwined and …

Addressing the key challenges for drug safety professionals

The regulatory environment is fast changing and the drug safety industry is facing significant hurdles in implementing standards globally. It is becoming increasingly challenging to meet all regulatory requirements effectively in the current globalised marketplace. Stay on top of pharmacovigilance requirements with updates directly from the regulators, agencies and industry who will show you how to implement regulatory standards globally. Learn …

Press release: World Drug Safety Conference hears call for wider use of cognitive safety testing in drug development

April 30, 2015 In a call to the pharmaceutical industry at the World Drug Safety Conference in Chicago last week (April 22 to 23), a leading developer of cognitive assessment software, Cambridge Cognition plc (Cambridge, UK; LSE AIM: COG), stressed the increasing regulatory and clinical need to expand cognitive safety testing beyond CNS-targeted drugs. Speaking to an international audience of …

Conducting a clinical safety review in drug development: the regulatory environment

Regulatory bodies have increased the pressure on pharmaceutical companies to measure and monitor the risk of cognitive adverse events associated with investigational treatments. At the same time, companies are becoming aware that monitoring the cognitive properties of investigational drugs can help minimize the risk of late stage failure in drug differentiation. The early stages of drug development programmes aim to …

Press Release: MyMeds&Me announce collaboration with Oracle Health Sciences

Oracle Argus Safety customers gain access to the Reportum® solution to further streamline and strengthen their Pharmacovigilance operations London, UK, 25 March, 2015: MyMeds&Me, a leading SaaS provider of web-based adverse event and product quality capture solutions for life sciences, today announced their collaboration with Oracle Health Sciences to provide the Reportum® solution to Oracle Argus safety customers. This collaboration …