Rare diseases

Sharing the mission to conquer rare diseases

Closer collaboration between pharmaceutical companies and patient organizations will accelerate drug development At an ever-quickening pace, biopharmaceutical companies and patient advocacy groups are banding together to hasten development of new drugs for rare diseases. Advocacy groups rely on their partners for financial and scientific support while providing access to repositories of patient data – the key to understanding rare diseases …

Adis

Adis launches services to support pharmacovigilance departments

Adis Pharmacovigilance will help pharmacovigilance teams to face the challenges of regulatory literature monitoring. Under the name of Adis Pharmacovigilance, Adis, a leading global provider of drug information, has launched an expanded range of services to support pharmacovigilance departments. This new suite of services includes monitoring special situation Individual Case Safety Reports (ICSRs), local literature and customised source coverage, ongoing …

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 …

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 …

Diagnosis in neurosurgery

Remote intra-operative diagnosis in neurosurgery

Graham McHardy CSci FIBMS Department of Pathology, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK   The introduction of digital slide scanning for remote reporting has restored an important service for patient healthcare at a Scottish hospital Telepathology is the process of digitising histological images for transmission electronically to remote centres, often for the purposes of diagnosis. Some telepathology systems employ robotic microscopes, which can be controlled remotely in order …

Abbot Laboratories Whitepaper

Whitepaper: Considerations in Purchasing a LIMS

Randy C. Hice | Abbot Laboratories Many scientific enterprises find themselves in need of a Laboratory Information Management System (LIMS) to replace an incumbent system, whether an existing commercial application, an amalgam of systems, or an in-house solution. Once the decision has been made, the selection and deployment of a new LIMS should move quickly and decisively. This white paper …

genomeweb whitepaper

Alternative Proposals for Lab Test Regulation

Are There Opportunities for Consensus? A GenomeWeb Report February 2016 Amid multiple proposals on LDT regulation, are there opportunities for consensus? By Turna Ray The lab industry entered 2016 in a staring contest with the US Food and Drug Administration that began two years ago when the agency released its draft guidance on regulating laboratory-developed tests (LDTs). During the course …

Clinical Outsourcing

Recoding the Life Sciences Value Chain with Digital DNA

Take a look at the penetration of digital technologies within and across the life sciences value chain, and see how some organizations are digitally reimagining their businesses to drive growth, boost productivity. Life sciences companies need to generate higher revenues at reduced costs to sustain innovation. To achieve this optimal scenario, the industry is building new portfolios, expanding into new geographies, …

TCS whitepaper

Reimagining the Clinical Trials Process through Digital Disruption

Conventional clinical trial processes require significant time and resources to be invested for data cleaning, monitoring, and reporting to the concerned regulatory authorities. This directly influences the cost of the trial, and thus the time to market. Explore how digitization of clinical trial processes can help transform the clinical research industry. The clinical trials industry manages large volumes of patient data …