Evidence & Performance Blog

LSIT (Life Sciences Information Technology)is a non-profit organization bringing together several industries to build the first Good Informatics Practices (GIP) guidance document to assist IT in 5 areas: compliance, standards, best practices, risk mitigation and return of investment. GIP is the guidance for improving quality and trust of IT within life sciences and healthcare.

GIP guidance document compiles standards in one reference guide for an IT system of a life science or healthcare environment.

All functions within a life science organization require significant use of multiple IT platforms. Their intellectual property, knowledge management and data are on IT systems that must be trusted and secure.

The integration of IT into Life Science and Healthcare has a “real potential for reducing both the time and cost of bringing new medical products from discovery to the patient. The one main inhibiting factor is “trust”. Trusting that these very complexes IT tools, computational processes, and resulting data are, in fact, accurate and scientifically valid, is critical for all stakeholders and gatekeepers alike”.

More information is available on http://www.lsit.org/

Lorena Levi, Trainer at Fundacion Cecilia Grierson in Argentina, is sharing with us her experience in operational and performance management in South / Latin America.

Lorena and myself talked about this in the past week, and I am now sharing her thoughts with you. Read more

Christophe De Vleeschouwer, Manager Medical Operations for Cordis Medical (a Johnson & Johnson company) in Belgium, is exposing his thoughts and needs about measuring performance for large cohort clinical registry. Christophe has met us last week, and Alex took his confessions. Read more

In your opinion, and based on your experience, which of the following root causes is curbing good clinical trial performance:

- Lack of methodology to assess metrics of performance, discontinuing the enhancement of informed decision
- Disparate and dispersed critical data, making difficult to have an integrated report “dash board” at a glance
- Isolated teams, creating painful communication loops and useless delays
- Other, please explain..

Leave us a comment with your answer !
We will write an article about the root causes of bad performance very soon, and it would be very useful to have all your thoughts on it !

Thanks

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.

Read more

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

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!

Read more

ClinPhone, the world’s leading Clinical Technology Organization, will be acquired within the next couple of months.

CRO Parexel already made a $182 million bid, however Quintiles is discussing the acquisition azs well, and if they agree it will most likely be more than what Parexel offers.

Read more

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

All new medical products (drugs and medical devices) must follow harsh process of clinical development.

Starting from the earliest stage to very last step in the process of the clinical trial, there is place for potential delays and unexpected costs. Read more