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

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: www.makrocare.com
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