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The rules of digital patient engagement - PMLiVE

The rules of digital patient engagement - PMLiVE | CRO | Scoop.it
The rules of digital patient engagement PMLiVE In-house research conducted at contract research organisation (CRO) Quintiles suggests that 58 per cent of all patients are never offered trial participation, while external studies suggest it may be...
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Business & Decision annonce l'acquisition de Ceri Médical - Decideo

Business & Decision annonce l'acquisition de Ceri Médical - Decideo | CRO | Scoop.it
Business & Decision annonce l'acquisition de Ceri Médical Decideo Le Groupe Business & Decision, consultant et intégrateur de systèmes international, annonce l'acquisition de Ceri Médical, entreprise spécialisée dans les études...
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Why Clinical Trials Need Mobile Health Tools: Can CROs be Replaced?

Why Clinical Trials Need Mobile Health Tools: Can CROs be Replaced? | CRO | Scoop.it

I have previously written why mobile technologies need clinical trials.  I would now like to discuss why clinical trials need mobile technology.

For readers not familiar with clinical research, a CRO (clinical  research organization)  is “…an organization that provides support to the pharmaceutical and biotechnology  industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. (Wiki)”    CROs as we know them today started in the late 1970s and early 1980s and have grown as a part of Pharma R&D budgets from 4% in the 1990s to close to 50% in the mid 2000s.  In a previous post on why Pharma needs mobile apps, I briefly mention their potential role in clinical trials.  I would like to discuss this in more detail now.  The cost of performing clinical trials is increasing significantly. Technology including mobile technology and analytics can decrease these costs, but the challenge is for both business models and the research processes to adapt around them. This presupposes that the technologies can perform trials well.

In an excellent paper Transforming the Economics of Clinical Trials, the authors discuss the introduction of technology in clinical trials: “Over the last decade, electronic data capture (EDC) has made some progress in transforming this [business] model. In an EDC-enabled environment, paper forms are replaced by electronic forms, whereby sites enter their data into an electronic database. This technology has produced some efficiency gains as edit-checks reduce the cost of the manual data-query process. However, the EDC platform was largely embedded in the traditional clinical research business model, with legacy concepts around site monitoring and validation. New opportunities for central statistical monitoring of data in these systems were not widely embraced)…Patient screening and recruitment costs remained largely unchanged.”  They then suggest the mining of EHRs for data for the screening and recruitment of patient research subjects, and mobile technologies for direct data collection. What is also keenly pointed out is the current absence for a technology-based business model. The report goes on to discuss monitoring of trial sites. Both the European Medicines Agency and the FDA have endorsed centralized monitoring of trials via technology on a real-time basis.

One company providing mobile tools for clinical trials is exco intouch.  InVentiv Health is a CRO which has recently become active in the mobile side of clinical trials. InVentiv bought a stake in Mytrus, a company that has mobile technology which facilitates obtaining informed consent for clinical trials.

Recruitment of patients is another aspect of digital technology in clinical trials. Pfizer used social media to recruit patients for a clinical trial of Detrol  One company hosting 200,000 patients in online communities which gather data on 150,000 disease states,PatientsLikeMe  has signed agreements with pharmaceutical companies to match patients with trials using its clinical trial search tool.

Other advantages of mobile clinical trials, as I see them, include less biased recruitment via crowdsourcing, a dramatic reduction in costs, better medication tracking via pill sensor technology (Proteus Digital Health), and faster reporting of adverse events (which can potentially save lives and stop negative studies earlier via transmission to the Data Safety Monitoring Board),  and more timely analytics and trial reporting. In addition, they might lend themselves to more comprehensive or efficient audits, and will strengthen the assistance of caregivers (who can receive and transmit data with/for the patient) in the trial. 

     While I do not believe that mobile technology will replace CROs, I do believe that it will significantly reduce costs and improve procedural inefficiencies and accuracy. The digitalization of clinical trial data represented a significant step in improving process and quality of trials. Making it mobile will take it to an even more higher level.

 


Via Plus91, Sergey Ruseev
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ACRES Names Katherine Madigan VP for Global Alliances and ... - PR Web (press release)

ACRES Names Katherine Madigan VP for Global Alliances and ... - PR Web (press release) | CRO | Scoop.it
ACRES Names Katherine Madigan VP for Global Alliances and ...
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Biopharmaceuticals Benefit State - The Ledger

Biopharmaceuticals Benefit State - The Ledger | CRO | Scoop.it
Biopharmaceuticals Benefit State The Ledger Working in collaboration with the state's university medical schools and science centers, hospitals and contract research organizations, biopharmaceutical companies have conducted nearly 8,000 clinical...
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Interview with Clinovo CTO Marc Desgrousilliers | opensource.com

Interview with Clinovo CTO Marc Desgrousilliers | opensource.com | CRO | Scoop.it
Learn how Clinovo leverages open source technologies for improving the future of healthcare and clinical trials. (Why open source is the future of clinical trials: Clinovo is a Clinical Research Organization (CRO) ...
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PE's unclear role in CRO industry leaves sponsors 'uncomfortable ... - OutSourcing-Pharma.com

PE's unclear role in CRO industry leaves sponsors 'uncomfortable ... - OutSourcing-Pharma.com | CRO | Scoop.it
OutSourcing-Pharma.com
PE's unclear role in CRO industry leaves sponsors 'uncomfortable ...
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PPD set to conduct more clinical trials in Germany - PMLiVE

PPD set to conduct more clinical trials in Germany - PMLiVE | CRO | Scoop.it
PPD set to conduct more clinical trials in Germany http://t.co/eNeBrdXm3F #pharma
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Statitec pilote les essais cliniques du projet européen PhagoBurn ...

Statitec pilote les essais cliniques du projet européen PhagoBurn ... | CRO | Scoop.it
Statitec, CRO française spécialisée sur les études cliniques et épidémiologiques, poursuit son développement et revient sur son projet-phare 2013 : PhagoBurn, un projet européen visant à démontrer l'intérêt de la ...
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Aster-SGS : quand l'industrie des essais cliniques laisse ses ... - ActuSoins

Aster-SGS : quand l'industrie des essais cliniques laisse ses ... - ActuSoins | CRO | Scoop.it
Aster-SGS : quand l'industrie des essais cliniques laisse ses ...
ActuSoins
Le 31 octobre, les 88 salariés d'Aster-SGS, centre d'essais cliniques parisien, auraient du tous se retrouver officiellement au chômage, et le site parisien fermé.
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Parliamentary Committee Indicts Clinical Trial Industry - NewsClick

Parliamentary Committee Indicts Clinical Trial Industry - NewsClick | CRO | Scoop.it
Parliamentary Committee Indicts Clinical Trial Industry
NewsClick
Within a year, the number of clinical trials being conducted jumped to over 500 per year , from less than 100 per year in the pre-2005 era.
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Clinical trials in India

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Industries de santé : un contrat pour relancer la filière

Industries de santé : un contrat pour relancer la filière | CRO | Scoop.it

Dans le cadre de la stratégie lancée au début de l’année pour consolider et structurer les filières industrielles françaises, le premier contrat de filière des industries et technologies de santé (CSF-ITF) a été signé le 5 juillet. La signature intervient à l’issue du 6ème conseil stratégique des industries de santé (CSIS) tenu sous l’égide du Premier ministre, Jean-Marc Ayrault. Les industriels de la branche (LEEM, G5, AFCROs …) se sont félicités des mesures proposées.


Via Stéphane Crémier
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Stéphane Crémier's curator insight, July 24, 2013 12:06 PM

Le programme issu de lourds travaux préparatoires pour de grandes ambitions, en attendant les mesures pratiques...