Re-Imagining Drug Safety Powered by Genomics, Information Integration and Emerging Technologies

|| Whitepaper by Tata Consultancy Services. Pub. 17/08/2017 Abstract Scientific advancements, emerging technologies, and extensive information have created new opportunities for modernizing drug safety.  Simultaneously, the pharmacovigilance regulatory landscape is shifting to ensure improved safety for patients. This is the time to reimagine the  drug safety sector to transform it into an advanced, proactive and patient-centric practice. Introduction The global …

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 …

pra, whitepaper, human, liability, clinical trials

Download: Expert Solutions for Human Abuse Liability Trials

Human abuse liability data is now considered a critical piece of information during the new drug application (NDA) review process for most treatments involving central nervous system (CNS) indications and those with abuse deterrent or tamper resistant properties. As a global strategic partner for pharmaceutical and biotech companies in Phase I development, PRA’s Early Development Services (EDS) team is highly …

Tata, TCS, whitepaper, innovation, R&D, pharma

Download TCS Whitepaper: (P)re-scribing the Innovation Pathway

Over the past decade, pharmaceutical companies have progressively turned to outsourcing to achieve their organizational and R&D goals. The main objectives have been cost savings and crunching cycle times. Today, the outsourcing of R&D processes, including patient-facing and back-end processes, accounts for nearly a quarter of the industry’s R&D spend.  IT service providers present a compelling value proposition in clinical …

pra, whitepaper, human, liability, clinical trials

Download whitepaper: Risk-Based Monitoring for Late-Phase Research

The growing consensus among clinical researchers and regulatory authorities is that risk-based monitoring (RBM) is more likely to ensure patient protection and overall study quality, and allows for monitoring that can be more effective than the traditional model of routine visits to all sites with 100% source data verification (SDV). A number of factors are leading to the paradigm shift …

Download whitepaper: Bringing Clinical and Commercial Together

inVentiv Health at the forefront of Maximizing ROI through an Effective Process for Planning, Data Generation, and Communications Through their Clinical, Commercial and Consulting Divisions, inVentiv Health is uniquely placed to bring together science and strategy  in generated evidence. Their clients rely on them to ensure that their clinical initiatives align with overall commercial goals through effective planning, evidence generation …

Characterization of Recombinant Albumin as an Effective Multifunctional Excipient to Enhance Drug Stability, Novozymes

Provided by Novozymes: The correct choice of excipient in the formulation of a new or redeveloped drug product is critical for the success of any formulation program. Novozymes' recombinant human serum albumins (rAlbumins) offer drug manufacturers a powerful formulation solution by providing a quality product based on comprehensive understanding of both its physical and functional properties. These characteristics allow faster …