Indian Healthcare IT market & Oracle’s presence in Indian Healthcare

Dr. Mehdi Khalid Vice President, Healthcare and Life Sciences Industry Business Unit Asia Pacific and Japan at Oracle about key aspects of healthcare IT market in India & Oracle’s presence in this space.

DownloadHealth India 2010

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Oracle starts the Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs

The Institute is focused on research that will accelerate IT innovation to advance personalized medicine and the delivery of safe and effective   treatments and health care services to patients around the globe. OHSI will work in tandem with academic research centers, focusing on a targeted set of research areas fundamental to the R&D and health care delivery challenges facing health sciences organizations today. Research priorities currently include: artificial intelligence and semantic technology; genomic, genetic and phenotypic data analysis; data mining to support optimization of clinical trials; and predictive algorithms and other technology to advance patient safety and provide advanced decision support at the point of care.Academic institutions interested in collaborating with OHSI in these focus areas should contact OHSI representatives at Oracle http://linkd.in/bXf98c
Oracle starts Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs. This is exiting news and I hope we get to see the participation of Open Source Drug Development Network (OSDD) and initiative by CSIR India earlier supported by Sun Microsystems

Data Management and Integration for the Future of Clinical Trials webcast

Upcoming Webcast: Data Management and Integration for the Future of Clinical Trials

Attend this interactive webcast presented by Applied Clinical Trials and Oracle Health Sciences featuring speaker Tom O’Leary, Senior Vice President, Data Management, ICON Clinical Research and Claire Castaings, Vice President Worldwide Director, Clinical Data Management Sanofi-Aventis. This session examines the use of the latest electronic data capture technology to efficiently integrate critical data sources.

Webcast Details

Speakers:
Tom O’Leary, Senior Vice President, Data Management, ICON Clinical Research
Claire Castaings, Vice President Worldwide Director, Clinical Data Management, Sanofi-Aventis

Live webcast date and time: November 10, 2009 at 8:00 AM PT/11:00 AM EST

To register for this event, click here.

The integration of data from the various technologies employed in clinical trials continues to increase in complexity. The typical clinical trial today integrates data from IVR, EDC, ePRO & Laboratories, to name but a few. Achieving a seamless integration of data greatly improves the speed at which data is available, enhances the quality and consistency of that data, and reduces costs. The pharmaceutical industry continues to strive for this efficiency while reducing the cost of getting drugs to market. Outsourcing drug development to CRO’s using the latest technology platforms is a key strategy in this quest. This webcast will explore how a leading pharmaceutical company and ICON used the latest electronic data capture technology to efficiently integrate all critical data sources, ultimately enabling the continuous assessment of patient data.

In this webcast you will learn how to:

  • Have a deeper understanding of ways in which technologies can interface to integrate data
  • Understand how time savings were achieved in the provision of data to monitoring committees
  • Realize the benefits of working together where activities are outsourced and how the latest technologies can derive benefit

Register today for this thought-leading event!

How should you safely outsource pharmacovigilance to an Indian contract research organization?

Published in hte Indian Journal of Pharmacology. Edwards B. How should you safely outsource pharmacovigilance to an Indian contract research organization?. Indian J Pharmacol 2008;40:24-7

The articles focus on different types of CRO that operate in India and the concerns western companies should address before deciding to oursource the trial to Indian companies.

exerpts from the article

The heterogeneous concept of a Contract Research Organization (CRO) in India is that, a CRO might refer to independent locally owned CROs, an affiliate of a multinational CRO, one owned by a larger non-healthcare companies (such as an IT company wanting to move into pharmaceuticals), one owned by a healthcare or pharmaceutical company or a hybrid of a CRO and a site management organization. In addition, there are significant differences in costs and capabilities. Only a small number have experience in multinational Phase II and III studies sponsored by US or EU companies. Costs for CRO services can vary by as much as fivefold. For instance, the cost per monitoring visit can vary between $400 and $2500 per visit. Employee turnover can be as high as 60% (a healthy number in a Western CRO might be approximately 10-20%); 95% or more of investigators meet recruitment goals. However, although for US studies query rate are typically 10-20%, the rate rarely exceeds 5%. Thus, there is no cohesive business strategy to develop the Indian pharmaceutical sector with enormous amount of variations in existing CROs.

Sponsors should be aware that high rates of staff attrition and turnover study monitors may well impact a CROs’ safety capability. Previously training in pharmacovigilance and GCP is a major issue with very few training courses in India, resulting in not enough GCP and pharmacovigilance trained personnel. The consequence of these factors may lead to the more experienced sites becoming overloaded with projects and the better investigators conducting proportionately more trials. In addition, the more attractive sites for recruitment may indicate that medical investigators already have a high patient load for their normal clinical practice, squeezing time for research subjects. This point is critical because of the challenge of informed consent from illiterate patients as described in a BBC documentary. Thus, it is critical the CRO industry rises to the Quality challenge by building quality as an integral part of all processes. This indicates that recognizing the costs of quality control and quality assurance checks are essential, not just an overhead.

Multi National Pharma sell their Captive Clinical Research Facilities in India

MNC pharma companies to control 8% of $20bn worth Indian medicines market by 2015. According to a FICCI study more than 60% of trials in India is conducted by Global Big Pharma companies.  Indian Clinical Research arena is often compared to the Indian outsourcing success and hte wave of BPO industry success in India.

Multi national companies that launched their own captive BPO centres India have now sold them to Indian vendors,  that trend has grown, the likes of , GE, Citi Bank, all have sold their captive centres to Indian vendors

In curent wave or Indian CRO success in clinical research is compared to such trends. There may be a possiblity that the likes of Novartis, Pfizer, Lilly, Sanofi, GSK can sell their captive centres that focus on clinical research to Indian CRO’s.

But for the time being such ambitions by Indian CRO will remain as pipe dream untill they will move  away from “I can do it cheaper and faster than in west”- sales pitch. And gains credibility and resources to offer value added service to Global Pharma

For example Indian CRO can offer backend integration with Indian Medicinal chemistry experts and companies to provide drug re-licencing /re-positioning services. They need to think about offering these value add services. Following are some of the areas Indian CRO’s can look

1. what happens to failed Clinical Trial and how can Indian CRO help Global Pharma to Drug repositioning/Re-profiling of drugs

2. How can Indian CRO provide Pharmacogenomics  services with clinical trial

3. How can Indian CRO help in personalized medicine initiatives

4. Even though it serves the vested interests of Global Pharma how can Indian CRO help in Extending patents of existing drugs with ANDA and NDDS

5. Pharmacovigilance and Post -Market Surveillance for Risk Assesement and Risk Mitigation

6. Data Warehousing and Data Mining by integrating clinical and non clinical data from multiple studies

7. Drug Life cycle management services

8. Generating Key opinion leaders and KOL platform by using data from multiple trials and resources

9. Premarketing Clinical Drug Safety and Risk Assessment

10. Designing Pharmacoepidemiology and Pharmacoecconomics stratgey and Aiding Evidence based pharmacotherapy


New Momentum Teams with Oracle to Help Reduce Counterfeiting in the Life Sciences Industry

New Momentum, a leading provider of SaaS‐based anti‐counterfeiting and channel integrity solutions, is working with Oracle to help pharmaceutical companies combat the escalating problem of counterfeit drugs and meet new regulatory compliance requirements.

According to the Center for Medicine in the Public Interest, worldwide pharmaceutical counterfeits are expected to increase by 13% annually nearly twice the pace of legitimate drugs. This means that counterfeit drugs could become a $75B industry by 2010. As these bad drugs flood the market, patient wellness is at risk and so are manufacturers’ revenues and brand reputation. This growing counterfeit problem, combined with the expected federal regulations for serialized drug products and electronic pedigrees, creates significant challenges for pharmaceutical companies.

New Momentum’s CEO, Stuart Clifton, commented, “The best way to meet these challenges is to incorporate internal enterprise and supply chain data with external data on counterfeit suspects and activity. That’s why we’re working closely with Oracle’s Life Sciences team to provide the first solution to offer pharmaceutical companies the ability to track units through the supply chain as well as quickly identify and find counterfeits.”
Oracle is focusing on helping manufacturers with a total solution that includes the ability to serialize each sellable unit and then track that unit through the supply chain via electronic pedigree. By integrating its 24/7 real‐time view of counterfeit suspects, New Momentum expects to help pharmaceutical customers be proactive in their anti‐counterfeiting efforts and comply with serialization and pedigree mandates. Prototypes of this solution will be demonstrated at Oracle OpenWorld, New Momentum Booth #2619A and Oracle Booth #S‐082 from October 11‐15 in San Francisco.

unSAP the Lifescience Industry with Oracle’s Healthy Lead in Lifescience Vericals

unSAP the Lifescience Industry with Oracle’s Healthy Lead in Lifescience Vericals. According to the latest IDC Insight Report
In the Oracle vs. SAP life sciences battle, Oracle gains a healthy lead. read the full report at

http://searchoracle.techtarget.com/news/article/0,289142,sid41_gci1368762,00.html

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