menu

QuintilesIMS Blog

Fresh ideas and insights from our experts around the globe

distribution
Brazilians flock to pharmacies: How healthcare companies can bolster sales by embracing this shifting shopper trend
Filtered by 'Risk' ×
Chantal Sfeila
How to manage and mitigate risk in global clinical trials.
Read More
Nimita Limaye
Risk-based monitoring can add considerable benefits to the research environment, but companies need help figuring out how to implement these programs and track results.
Read More
Margot Stam Moraga
Why your signal management program may not be as effective as regulators would like.
Read More
Robin Douglas
A centralized approach to monitoring has been shown to improve data quality and patient safety while lessening the burden on-site staff.
Read More
Marie McDonald
How supplier assessments uncover problems before they impact quality.
Read More
Matt McKeever
In today’s high-pressure, cost-focused economy, biopharma companies are constantly looking for ways to optimize spending so they can focus their time, resources and expertise on projects that generate the greatest return on investment. One area where companies can find such opportunities is in managing their portfolios of mature products.  Companies invest a huge amount of time and money every year into maintaining the safety data, regulatory affairs and benefit-risk management for established products. These are all vital management functions, but in most cases they could be managed much more effectively. As products age, companies face pressures to shrink maintenance costs and to grow or maintain revenue, all while still ensuring regulatory compliance and reducing risk. Companies...
Read More
PeterLassoff
After spending more than a billion dollars to develop a drug, it needs to be commercialised in as many global markets as possible before the patent expires to obtain the biggest return on that considerable investment. It is a sound strategy but is fraught with risk. While most companies recognise the challenges around understanding a new set of regulations, marketing demands and sales cycles, they may not be aware of the potential risk to their intellectual property when making regulatory submissions. In emerging markets, we have heard of several horror stories in which proprietary Chemistry, Manufacturing and Controls (CMC) information from submissions ends up in the hands of local manufacturers, and reports from clinical studies appear in public domain. In one instance, a company...
Read More
StellaBlackburn
Risk is an inherent part of every drug development project. Pharmaceutical companies face financial risks, regulatory risks, market risks, and most importantly – patient safety risks. Figuring out how a drug will impact patients across the spectrum of target users, and whether it is safe for all potential patients, is a vital step in validating its safety and efficacy. Which is why risk management planning has become an important part of the drug approval process. Medication risk management plans, which are known as Risk Evaluation and Mitigation Strategies (REMS) in the US, and Risk Management Plans (RMPs) in the EU, have been embedded in the regulatory system for more than a decade as a way to ensure that the benefits of a drug outweigh its risks by as much as possible.  A drug...
Read More
Nathalie Horowicz-Mehler
Even when biopharmaceutical teams engage with payers early and often through the development process, payers may still balk at the projected price of a new treatment especially if cheaper options are on the market or if the target population is large. That can be the death knell for an innovative asset. But there is a solution. If payers won’t embrace your pricing strategy, consider risk-sharing as a way to get them on board. When agreement cannot be reached on price or on the reimbursement terms, risk-sharing agreements allow less restrictive access in exchange for the manufacturer bearing incrementally greater financial risk, thus ensuring the asset is prescribed and used. Some examples of risk sharing models include: Outcomes-based risk-sharing: These agreements...
Read More
RickSax
The incredibly high failure rates seen in clinical trials has pushed biopharmaceutical companies to aggressively manage the time and cost of these initiatives as a way to reduce their risk. Such efforts can deliver incremental savings on trial design, but too often these short-term gains increase the risk of long term losses.  When clinical trial project teams face relentless pressure to cut costs and shorten time frames, it pulls their focus away from the long term goals of identifying the most promising drug candidates and delivering them to market. If they are being judged on how much they spend on every trial, they can’t make the best decisions for the long term success of a drug. Cutting overhead for example, may achieve short term savings goals, but it lessens their ability to...
Read More