Zenith Serialisation Whitepaper

Overcoming the practical challenges of Pharmaceutical Serialization

Is Pharmaceutical Serialization on your radar? With new regulations either being implemented or pending should it be? Serialization entails adding a unique identifier to single saleable units of prescription and some other medicines so they can be tracked and authenticated throughout the supply chain. Requirements for serialization are already active in some parts of the world and they will be …

Drug Safety Europe 2016

Ensuring Compliance for Cloud: A Risk Management Guide for Life Sciences Organizations

In an effort to manage cost pressures, optimize operational efficiencies, and build robust IT capabilities, the life sciences industry is also shifting to the cloud. However, being a highly regulated industry, players face significant compliance challenges while leveraging the cloud. In addition to managing security risks in a shared computing environment, organizations also need to ensure that regulatory commitments are …

Algorics

Press-release: Mednet Solutions announces technology partnership with Algorics

May 19, 2016 Minnetonka, Minn. & Houston, Texas – MedNet Solutions, an innovative SaaS-based eClinical technology company that supports the entire spectrum of clinical research, and Algorics, a provider of cloud-based clinical analytics solutions and software for the global life sciences industry, today unveiled their strategic technology partnership designed to provide superior risk based monitoring (RBM) functionality to MedNet’s customers …

Algorics

Press- release: Algorics releases latest version of its acuity solution

Houston, TX, USA, For Release: 5th August 2015. Algorics, a provider of clinical analytics solutions and software for the global life sciences industry, today announced the release of the latest version of its acuity solution – designed for use by pharma, biotech, CRO and academic organizations to drive regulatory compliant processes around management of risk. The acuity solution allows organizations …

Ebook: Your essential guide on trends, regulations and new technologies in Drug Safety

Drug safety must continue to evolve to meet heightened patient expectations and the fluctuating regulatory climate. It is becoming critical to exploit opportunities offered by emerging technologies, big data and personalised healthcare. To succeed in this new environment, we need to assess the regulatory updates; we need to examine how to implement regulations strategically and operationally in addition to discussing …

Risk based monitoring

Risk Based Monitoring

At the 2014 Clinical Outsourcing & Partnering World event, Geoff Taylor, Eisai, gave a presentation on “Risk Based Monitoring”. Taylor’s presentation defines risk based monitoring and demonstrates its effectiveness and added benefits such as enhanced study performance, fewer monitoring visits, and targeted SDV. To discover more, Download and learn: What is “Risk Based Monitoring”? Why are we Interested? What’s Different? Points to Consider …

Risk, Based, Monitoring, Experience, Update, Clinical Outsourcing

Risk Based Monitoring (RBM) A two-year experience update

  At the 2014 Clinical Outsourcing & Partnering World event, Elspeth Carnan, Amgen, gave a presentation on  “Risk Based Monitoring (RBM) A two-year experience update”. Download and learn: Risk Based Monitoring The Amgen and Quintiles Partnership Where are we today Data Review Flow & Flexible Monitoring Overcoming Challenges What’s to Come with RBM at Amgen Download Presentation Found this interesting? Join …

trilogy, drug safety, risk

Download whitepaper: Risk management plans – New challenges for a new era

  The risk management plan (RMP) is currently a hot topic and the focus of much discussion in industry due to the recent overhaul of the RMP guidance template. The complexity of the new RMP has introduced many challenges in preparing a high quality document compliant with all requirements, not least in the production of the newly legislated Part VI.2 …

Managed Entry Trumps Risk Sharing

Mr Ed Schoonveld, Managing Principal, Market Access & Pricing Leader, Author of ‘The Price of Global Health’, ZS Associates Inc   Managed Entry Agreements (MEAs) moves beyond sharing risk to targeted solutions that address evidence gaps and financial constraints Since 2000, pharmaceutical and biotech companies have engaged in agreements with government and private payers across the world to gain market …