Archive for the 'Methodology' Category
Assessing the performance of CROs
Assessing the performance of CROs
Pharmaceutical and biotech companies want to speed up the research and development process whilst adhering to stricter guidelines. That’s why CRO’s are primarily selected on their scientific expertise and the cost/value ratio.
If R&D companies have always had a ‘feeling’ about their CRO, they are now more and more looking for facts in assessing their performance. This can only be done by “Choosing the right metrics” and “Deploying the right tools to evaluate these metrics”. Read more
No commentsPharma. Challenges: Executive Interview with Dr. Pierre Le Sourd
We had the pleasure to meet Doctor Pierre Le Sourd, former President of Bristol Myers Squibb France and most recently President of the Leem (The French Pharmaceutical Companies Association).
Mr Le Sourd brings us 30 years of pharmaceutical experience to help us understand current challenges and perspectives in this industry.
4 commentsClinical Trial Performance Metrics Event !
The 6th annual conference will take place in London from January 27th to 29th, 2009!
We are of course looking forward for this unique event in Europe, as its focus is Performance, and Metrics used to accelerate development, improve quality and streamline decision making.
By joining the performance metrics event, you will:
- benefit from the experience of top pharmaceutical companies like JnJ, AstraZeneca, Eli Lilly, Astellas Europe, Baxter, Bayer, CMR (Center for Medicine Research) !
- understand how the implementation and application of performance metrics can improve your clinical trials
- benchmark your performance metrics procedures: gain vital advice from leading pharmaceutical companies from across Europe and globally
- keep up-to-date with the latest performance metrics issues including using metrics to predict risk
We are very pleased to announce that we will be joining the event, not only listening to the conference but also actively participating!
Alex. Durand-Salmon, Co-author of the blog will share his experience regarding Performance dedicated to Service Providers in the conference “Case study: A real life example of using metrics to assess the performance of a service provider”.
Also Christophe De Vleeshouwer, Manager Medical Operations at CORDIS (Belgium) who already shared with us his experience regarding clinical trial performance (will held the conference “Critical guidance on the choice of metrics: how to best use them in the frame of pre- and post-market studies and registries”.
If you are interested in listening to the 2-day conference, feel free to visit www.informa-ls.com/metrics and get registered.
Should you not be able to go this event, please let us know your particular points of interest, and feedback you would like to have from this conference !
Shortly after the event we will give you an update !
Thanks for your participation !
No commentsEDC Metrics Survey
I’m coming back on initiatives around Performance Metrics in the Clinical research area. Someone forwarded me this interesting link: http://www.eclinicalforum.com/
You can find a very good and complete survey of companies involved in conducting EDC trials to assess the feasibility of establishing standard metrics for the assessment of EDC performance. It is not a new document (June 2004) but it gives very useful and focused approach to benchmarking EDC performance.
No commentsWorkload measurements
As we know there is currently no reliable data on workload measurements nor proven methods which results in unrealistic performance expectations, excessive workload and inefficiency. It is crucial to know the time required to complete a dedicated task, the necessary resources to participate to a clinical trial.
The European Organization for Research and Treatment of Cancer (EORTC) has developed a Workload Measurement Instrument (WMI), used to record the time spent on main activites and the to calculate the cost of recruiting subjects to oncology trials.
2 commentsPharma 2020 : The vision - which path will you take?
If you want to understand why the pharmaceutical industry is currently undergoing a transition, I am recommending you to read this interesting report from PricewaterhouseCoopers.
PWC clearly “indicates that the current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets. In order to make the most of these future growth opportunities, the industry must fundamentally change the way it operates.”
As I mentioned earlier, it is clear that the Pharma. must quickly find the way to improve its R&D productivity. For us, it is only by measuring the performance that the companies are able to set goals and drive for improvement. This has been demonstrated in others business as finance, and ultimately will prove itself in Drug or Medical Device Development.
Do not hesitate to share your impression with us!
Pharma 2020 : The vision - which path will you take?
A report from PricewaterhouseCoopers
Trial results in 7 weeks – possible?
YES ! This is just amazing!
Time between last patient’s visit and announcement of the clinical trial results took a bit less than seven weeks! Yes seven weeks, where it usually takes months, to get the final results out!
This happened to a sponsor with the help of Nextrials support and its EDC Software Prism!
Non-exhaustive listing of clinical trial performance metrics initiatives
Since we started, with Evidence, to talk about performance metrics in the clinical environment, I’m trying to obtain a clear picture of the active actors in this domain of expertise.
After few months, it becomes clear to me that it is not so easy to obtain this picture perhaps because we are facing a really emerging market with very few initiatives so far. Nevertheless, I think that this type of information could be very valuable for everyone in the community who shares our interest in this matter.
No commentsEvaluating the Service Providers’ performance: a need as urgent as strategic for the sponsors
As the sponsors are more and more focused on the clinical trial performance, they now also seem focused on their service providers. Let’s see why they are interested in their provider’s performance, how they can get to results and at the bottom line what impact it will have on their future trials. Read more
No commentsClinical Trial Performance - why should we assess it?
Have you ever been asked to “reduce the costs to develop new pharmaceutical products and / or to reduce time to market”? Yes? Then you will be interested in sharing your experience and ideas on this matter!
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