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IVRS in Risked Established Monitoring

IVRS in Risked Centered Monitoring

Tejaswini Sawant, RBM - SME, TCS

As per current styles in specialized medical trial industry and approaching technology, Integration of data from IVRS to Risked Established Monitoring Portal will help in efficient traffic monitoring of patient involvement in study, drug dispensing and supply management. Occurrence of mistakes and risk in a scientific trial drug management can be managed using the predictive analytic model and result in mechanism. This may enhance patient safety, ensure good quality data and retain the integrity of clinical trial in this high complex environment.

Introduction

The last 2 decades have seen an instant increase in medicine development department of pharmaindustries with major concentrate on producing new drugs whichintend to improve the quality of human being life. However with this there is also an increase competition amidst the pharmaceutical companies to be the first ever to develop the drugs. In order to develop and achieve the intellectual privileges over drugs the pharmaceuticals need to first patent the medicine by seeking the relevant regulatory and authorities licensing approval. It really is expected that the pharmaceutical industry conducts the professional medical studies on these new discoveries to judge the efficiency and the medial side effects on real human assignments.

The competition on the list of pharmaceutical business has increased the complexities in general management of specialized medical trial like retaining high integrity data, guaranteeing the patients well-being is safeguarded, minimizing the errors made. 1

In order to really have the best value data from the scientific tests the FDA focus on --

"Increased use of electronic systems and improvement in statistical assessments, present opportunities for different monitoring methods that can improve the quality and efficiency of sponsor oversight of medical trials"2

This resulted in development of tools of technology like Interactive Speech Response System (IVRS) made to reduce errors and simplify the professional medical trial management process.

This newspaper is to understand the use of IVRS in Risked Based Monitoring.

Pharmaceuticals are placing a lot of efforts in producing new drugs in market. However the process has become more complex because of the following factors:

  1. Diverse regions of the world resulting in increase in the amount of sites
  2. High patient population

In order to handle these complexities, IVR systems are developed to facilitate overall drug management - manage the move of medicine at sites, patient randomization, dose titration, unblinding and expiry day updating. IVRS is a technology where in a cell phone is used to gather information from databases or enter in the database. IVR system also supplies the facility to incorporate it with other management alternatives and applications to improve the management of professional medical trials by figuring out early risk indications. Thus, IVRS technology has helped in effective management of professional medical trials by reducing the cost to scientific trial and release of faster technology. 5, 6

Several factors are travelling the globalization of clinical tests. Commercially, sales of pharmaceuticals in 2009 2009 grew at 3-5% in Europe and the United States, in comparison to 13-15% in Asia, Africa, and Australia, and 10. 6% in Latin America. Additionally, IMS has forecasted sales development of 3-6% for United States andWestern Europe, and 12-15% for Latin America, Asia, Africa, and Australia each year through 2014. 7

With concentrate now moving to Emerging countries for patient recruitment as well load on pharmaceutical companies to lessen scientific trial cost, almost all of the companies are suffering from IVRS that may provide Pharmaceutical companies with a study-wide view of patient and medication supply activity which will help monitor progress, anticipate problems, and ensure preventive actions are set up. It is seen that the EDC growing companies have started out developing IVRS services and viz versa which includes further reduced the clinical trial cost by 40 %. The benefit of collaborating these service has reduce the amount of systems necessary to access the data, reduced the data entrance and duplication errors across the systems and ensured sequential stream of information.

Biopharmaceutical companies have began adopting professional medical technology to help improve their R&D productivity. Today, sponsors are performing intricate global studies effectively through use of new technology to help accumulate safety and efficacy data for submission to medical authorities. To accomplish this, they need usage of real time data to execute analysis and provide decisions with respect to the clinical studies hence the need for technologies like IVRS

IVRS is extensively use within global clinical studies for patient management, and medication supply management.

Patient level:IVRS is utilized in real time monitoring of patient recruitment - testing and randomization, assigning of review drug, handling patient visit schedules and accumulate trial data. Some of the features of IVRS in remote monitoring are robotic gain access to of information, 24 /7 availability with cost efficiency. IVR system offers a faster and versatile way in the registration of a patient and integrating the same into EDC system. 3

  • Integration of the topic screening data from IVRS and other merchant portals like EDC, CTMS, Labs with Risk Based Monitoring Website can help era of proactive causes to the website by Central Monitor regarding patient eligibility for the study.
  • On recruitment of first subject at site, Central keep an eye on can raise trigger for an onsite trip to assess risk. This can help minimize the eligibility deviation as well as proactively predict the enrollment rate for the analysis.
  • Integration of visit data received from IVR system in RBM portal will also predict the topic level compliance to the analysis medication, skipped visit and anticipate the retention rate for the study.

Making the enrolment and retention predictable and productive will be a major quality profit to pharmaceutical industry.

Study Level: Proper medication accountability management is vital to ensure patient security, maintain study timelines and protect integrity of the medical trial data. Advancements in technology have rendered paper-based medicine accountability records obsolete. Electronic medication accountability is a function that can be added to a preexisting IVR system. IVRS is suitable for drug accountability since it tracks medication dispensing items by warehouse, depot, and site location, and by batch, bulk whole lot, packaging step, label group, expiration date, temps excursion and patient allocation. 4 Stylish technologies are actually included in IVRS to estimate and administer complex dosage titrations.

Integration of data from IVRS for site level drug resource and patient level with Risk Centered Monitoring website can help central monitor to forecast the drug supply needed at the website. The feature will include:

  • Triggers for acknowledging the resupply received at site,
  • Return of review drug predicated on the expiry night out.
  • RBM can also enable review level visualizations to help professional medical trial management to plan and track the drug resource on a continuing basis.

Trials affecting Patient Related Benefits (Advantages), IVRS is utilized to accumulate data immediately from patient like ramifications of study medicines on the patient's standard of living, including undesireable effects, this helped sponsor manage patient basic safety and timely distribution of data to health specialist. .

In studies involving blinded laboratory results, IVRS can be used to collects real time data straight from sites, patients and labs and offer real time laboratory results and reports. Using IVRS, alert system can be sorted out for medication dosing and visit reminders for trial patients.

IVRS is perfect for adaptive trials because they are simple to apply and use and offer flexibility to execute adaptive changes.

IVRS has gained huge approval among sponsor because they provide real-time benefits in patient management, study medicine management, blinding, reporting, systems integration and low costs. Some of the great things about IVRS are:

  • It provides real-time feedback from centralized repository which help researcher allocate the right treatment and help better aid statistical analysis
  • It enhances blinding process by allocating treatment group in controlled and unbiased manner
  • Robust and automatic system provide real time reports to review manager which allow proper research planning, ensure site compliance
  • Low cost - initial study setup fee with zero-maintenance fees is the costs to the sponsor

However certain troubles seem to be to persist in implementation of IVRS in specialized medical trials:

  • Providing technical and study-related support to sites and patients within a trial in regional languages for global studies
  • IVRS set-up timelines on an average are three months, hence can impact examine start-up timelines
  • Redundancy in suppliers with the experience, functions, resources, and knowledge to control globaltrials
  • Proactive management of review materials to avoid delays
  • Reducing duplication in dataentries, and ensuing errors using IVRS could cause costly delays before data lock and statistical analysis.

Skill set used in development of IVRS technology are IT software specialist, Clinical data management, supply chain experts, statistician, and functions manager.

IVRS also plays an integral role in Risk established monitoring. As aware that FDA has published guidance which suggests reduced amount of onsite monitoring stop by at be changed with alternative approaches to monitoring, with specific support for centralized and risk-based monitoring. The direction states, "Several publications suggest that data anomalies (e. g. scams, including fabrication of data and other non-random data distributions) may be more readily detected by centralized monitoring techniques than by on-site monitoring. "

There keeps growing evidence that using centralized monitoring the recognition of non-compliance and data fabrication is more than using the traditional 100 % SDV model. Real-time integration of data from IVRS, EDC, CTMS and other data portals in centralized monitoring portal help early detection of fraudulent, noncompliant, erroneous data, hence helps immediate precautionary and corrective at site, ensures good quality data and patient safety

  • In today's Internet-savvy world, Interactive Web Response Services (IWRS) are quickly swapping outdated and frustrating Interactive Tone of voice Response System. IWRS provides increased efficiency and productivity with lower rates. There is also a dramatic reduction in development cycles compared to IVRS. Sponsor company based on the study design, sites, logistic and budget decide after the use of IVRS / IWRS technology for the studies.

Thus integration of IVRS / IWRS technology with centralized and risked established monitoring modelwill help the pharmaceutical industry manage the scientific trial efficiently by proactively lowering the risks regarding the drug source management at patient and site level, ensure efficient patient monitoring and retain patient security.

References:

  1. http://www. ivrsdevelopment. com/ivrs_clinical_trial_management. htm
  2. Page 4 - Beyond SDV: Enabling Holistic, Strategic Risk-Based Monitoring - An Oracle White Newspaper - March 2014
  3. http://www. ivrsdevelopment. com/ivrs_clinical_trials_patient_monitoring. htm
  4. Page 3 - Electronic Medication Accountability Systems - Stefan Duerr, Associate Director of Project Management, Cenduit
  5. http://www. fermish. com/ivrs_clinical_research/introduction. htm
  6. http://www. appliedclinicaltrialsonline. com/node/244354?rel=canonical
  7. http://www. almacgroup. com/wp-content/uploads/Journal-for-Clinical-Studies-Nov-2010-Joe-Bedford. pdf
  8. https://www. criteriuminc. com/docs/science_tight_economy. pdf
  9. http://www. almacgroup. com/wp-content/uploads/IVRIWR-Sytems1. pdf
  10. http://www. almacgroup. com/wp-content/uploads/Mitigating_the_Challenges_of_Global_Clinical_Trials. pdf
  11. http://www. fermish. com/ivrs_services_for_clinical_research. htm
  12. https://www. criteriuminc. com/ivr-iwr. php
  13. http://www. merge. com/MergeHealthcare/media/documents/case%20studies/CS_integrating-ivrs-and-edc_1. pdf
  14. http://www. almacgroup. com/wp-content/uploads/Adaptive_designs_article2. pdf
  15. http://www. dsg-us. com/IWRS. aspx?menuclicked=Products
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