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Pharmacovigilance | Safety Medical Review
Pharmacovigilance | Safety Medical Review
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Pharmacovigilance | Safety Medical Review


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MakroCare is a Clinical Research Organization (CRO) providing Drug Safety and PharmacoVigilance, Literature search, PSUR Writing, Safety Medical Review and many other services.

MakroCare is a Clinical Research Organization (CRO) providing Drug Safety and PharmacoVigilance, Literature search, PSUR Writing, Safety Medical Review and many other services.

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  • 1. C A S E S T U D Y P H A R M A C O V I G I L A N C E A Simple Innovative Modification in the PharmacoVigilance Process Shows Great Improvement in Data Accuracy Introduction of an additional Quality Control (QC) process, using internally developed QC metrics made the PharmacoVigilance data much more accurate and much beyond expectation. Post-marketing surveillance (PMS) is needed to monitor the safety of drugs in the uncontrolled, real-world and post-approval environment. Pharmaceutical companies often outsource these PharmacoVigilance activities to CROs due to resource and time constraints. MakroCare performed PMS for one of the top 15 pharmaceutical companies in the world, based out of USA. Our client wanted PMS to be conducted for 15 products for the first year of Post-Marketing phase with renewal for subsequent years based on their satisfaction with our services. All drugs were marketed in USA and on an average 50 cases/day were handled by MakroCare PharmacoVigilance team. To handle this project effectively, we formed a team with 11 members - 5 Drug Safety Executives, 3 Call Center executives, 1 Medical Assessor, 2 Quality Control personnel and 1 Project Manager. Also, PharmacoVigilance was conducted in an ICH-GCP environment using 21 CFR Part 11 compliant safety database for Case Receipt as well as Adverse Event (AE) Processing: data entry, processing, analysis and reporting to regulatory authorities. PharmacoVigilance was conducted using our SOPs that were developed based on standard PharmacoVigilance practices. Also, our client had online access to the cases through the safety database. Random QC checks conducted by our client in the first month, found that the data showed 92.5% accuracy. Roughly, one in every 5 case was checked. This was a concern to the client since their staff was overburdened with the QC activities that they had to perform besides their regular activities. Client wanted better data accuracy and hence higher confidence level so that the QC checks could be brought down to one in every 50 cases, as per the agreed objective. To improve quality and reduce errors in case processing,we decided to introduce a QC step just prior to Medical assessment (Please refer Figure 1). For this,we developed a QC metrics system,whereby each entry in the AE Monitoring report was given a weightage. The allocation of weightage was based on how crucial those data entries were from a reporting perspective. Two QC personnel, trained in PharmacoVigilance, conducted QC on each case, before the case was forwarded for medical assessment. After implementing this QC step,random QC checks conducted by our client showed 98.5% data accuracy (Please refer Figure 2) and the trend continued to same levels for the next two months. ‘The significant increase in data 1
  • 2. Figure 1: AE Case Receipt and Management 2 CASE RECEIPT ENTRY INTO SAFETY DATABASE QC REVIEW BY SAFETY ASSESSOR MEDICAL ASSESSMENT QC MEDWATCH/ CIOMS REPORT GENERATION NEW QC STEP INTRODUCED Figure 2: Improvements in Data Quality after Introduction of New QC Step Figure 3: Reduction in number of cases checked in random QC after introduction of New QC step DataAccuracyin% 98.5% 92.5% Before new QC step After new QC step %ofCasesCheckedin RandomQC 2% (1 in 50 cases) 20% (1 in 5 cases) Before new QC step After new QC step accuracy led to higher confidence levels and satisfaction for our client. It was a big relief for the client staff and we achieved the target of random QC checks (by the client) down to one in every 50 cases (Please refer Figure 3), in a short period of about three months. This slight tweaking in the standard AE case receiving and processing workflow proved very effective in achieving high quality levels and also won us renewal of contract with our client for PMS in the subsequent years. Copyright © 2009 by MakroCare. All Rights Reserved. Visit us at: MakroCare,a global clinical services firm,provides clinical research support to pharmaceutical, biotechnology, and medical device industries. The company offers site selection, patient recruitment, clinical monitoring,quality assurance, medical writing,PMS/Pharmacovigilance,clinical data management, biostatistics and regulatory assistance. MakroCare has offices in USA (New Jersey, Illinois, Pennsylvania, California), India (Hyderabad,New Delhi,Mumbai,Bengaluru), Europe (Germany - Frankfurt) and Japan (Tokyo). About MakroCare