Abstract

The Oracle, ePharma Solutions, and Perceptive Informatics applies integrated and accessible EDC systems in pharmaceutical clinical trial’s data capture. However, Medidata Rave has become one of the major electronic data capture (EDC) vendor supporting some of the major pharmaceutical companies in the world (Uehling, 2005). One of the groundbreaking success of Medidata’s innovation is its capability in aiding pharmaceutical and biotechnology companies in achieving business and research goals. Besides the Medidata’s integrated EDC, data management and reporting systems, thesystem has achieved full recognition based on theproduct’s capability such as the technology’s user friendly design in supporting and sharing clinical data interchange standard consortium (CDISC), clinical data acquisition standards harmonization (CDASH) compliant eCRFs andthe Indian institute of technology’s (IITs) outcome studies. In addition, Medidata supports multiple languages in a single system.

 Clinical Trial Management Systems

Clinical data interchange standard consortium’s (CDISC) objective is to achieve a common language for clinical research. The importance of supporting a CDISC initiative cannot be overlooked in clinical research. Thus, the need for a CDISC integrated clinical trial is to promote a multidisciplinary, neutral, non-profit standards in a collaborative effort in developing global standards and innovations to streamline medical research while ensuring productive links with the healthcare systems (FDA. 2011). Furthermore, the CDISC aims to develop and support global-independent data standards which will promote information system interoperability in enhancing medical research and better healthcare system. Therefore, the importance of the effectiveness of a good clinical standard is to ensure patient’s safety through higher quality medical research with the intent to achieve operational values based on the economic of communion in freedom or bridging the lack thereof. In addition, the CDISC standard had been shown to decrease resources by 60% in general or 70%- 90% in the start-up stages when it is implemented at the beginning of the research process (FDA. 2011). Hence, the invaluable aspects of using a CDISC integrated standard allow for easy review of clinical data by regulatory agencies based on the international organization for standardization (ISO) or the European committee for standardization standard in an attempt to facilitate an efficient biomedical research integrated domain group (BRIDG). In other words, any data generated with a CDISC integrated Medidata is easily reviewed by any regulatory agency around the world, if the agency follows the same aforementioned harmonization standards (CDISC. 2010).

The clinical data acquisition standards harmonization (CDASH) is another invaluable asset in Medidata, which addresses the safety of research protocols. A CDASH-Medidata facilitates efficient capture of essential elements in a clinical study such as adverse events, concomitant medications, laboratories, inclusion/exclusion criteria, etc. (CDISC.2010). Hence, in clinical research, accurate notation and inclusion of a CDASH element is critical in evaluating the efficacy and safety of any investigational medicinal products. Most importantly, it allows the regulatory agency in assessing the regulatory aspect of the investigational medicinal products, in question.

In addition, CDASH integrated Medidata application generates an easy and strong appeal to sponsors intending in generating clinical data for regulatory submissions/purposes. The application of Medidata in respect to the aforementioned components, CDISC and CDASH, makes it possible to facilitate protocol-authoring and in-depth implementation services to accelerate start-up time (Medidata. 2012). Furthermore, Medidata uses expertise for project management, study design consulting and allow access to standards such as CDISC and CDASH standards expertise. Moreover, since most of the world’s clinical studies is globalized or outsourced abroad such as in India, Medidata supports Indian institute of technology’s (IITs) outcome studies and by design integrating the two systems to fit their needs. Also, Medidata uses and implement global support in multiple languages.

Apparently, the success and advancement of data management goals on a global scale is in part the vested interest in harmonizing medical terms (CDISC, CDASH, etc.), accommodating language barrier or scientific unit barrier such as body weight discrepancies (USA or Europe scientific unit preferences for example), incorporating a harmonized system to allow for easy interpretation and implementation of research data, and to effectively accelerate regulatory submission of research data. Perhaps, despite Medidata’s success and innovation with the EDC system, the implementation of webinars for training purposes is still a challenge and unreliable task (Borfitz, 2009). Therefore, differences in connectivity in different country’s internet systems, most of the times, makes it practically impossible to achieve an easy and uninterrupted inter-continental real-time webinar-training sections.

References

Borfitz, D. (2009). Medidata on a voiding the pitfalls of edc training. Retrieved from http://www.ecliniqua.com/eCliniqua_article.aspx?id=87004&LangType=1033.

CDISC. (2010). Clinical data acquisition standards harmonization (CDASH). Retrieved from http://www.cdisc.org/stuff/contentmgr/files/0/b3046b6653c1ddabbf6f4c1f647a9347/ files/cdash_std_1_1_2010_04_19_review.pdf.

FDA. (2011). Evaluations and studies of new drug review programs under PDUFA IV for the FDA. Retrieved fromhttp://www.fda.gov/downloads/ForIndustry/UserFees /PrescriptionDrugUserFee/UCM272444.pdf.

Medidata. (2012). Study design. Retrieve from http://mdsol.com/services/studydesign.htm.

Ohmann, C. (2008). Identification, evaluation and prioritization of possible common or compatible gcp-compliant data management tools for multinational trials. Retrieved from https://docs.google.com/viewer?a=v&q=cache:vNapjO4tNEYJ:ferran.t orres.name/download /ecrin/ECRIN_Report_D11_final_draft_031108.doc+Identification, +evaluation+and+prioritization+of+possible+common+or+compatible+GCP- compliant+data+management+tools+for+multinational+trials&hl=en&gl=us&pid= bl&srcid=ADGEEShhxQ9CG8XDcW2Ajm8iVk0lgYw74cnV2S_6vGGl11SiEH-O- _LdzmlpovmqRS30IyDft3b-958lcOVOY2YUZKuJ2aOFt__KbRV1LBcFtfTcMcernt6o LvBEJnunbNJhuORMTQtn&sig=AHIEtbTVNnG-ixqKJYiqCpNa3j7RUrQujw.

Uehling. M. (2005). Medidata enters the majors. Retrieved from http://www.bio- itworld.com/BioIT_Article.aspx?id=49008.