Max Neeman's Clinical Data Management service has been trusted by numerous global pharmaceutical, biotech and device companies. Renowned for its excellent planning and the utilization of latest technology, the data management team ensures high quality data, quick turnaround time and accelerated solutions for our clients.

1. Best Practices for Quality
Data Management

2. 2
Head of Clinical Data Management
Koteshwar Govind
Koteshwar Govind’s experience spans more than 10 years in Clinical Data
Management and Biostatistics. In his current role as Head of Clinical Data
Management at Max Neeman, he leads a team of >90 consisting of Project
Managers, Biostatisticians, SAS Programmers, Validation team, and Medical
Coders. He has managed 120 studies working with more than 40 customers
for Data Management and Biostatistics. He has expert knowledge of eClinical
processes, efficient design/build of an EDC data management system and
other clinical trial Data Management Systems [SAS, Clinion, and Oracle].
Koteshwar Govind has advanced expertise with clinical programming in SAS [>5 years] and
experience managing multiple, global studies as a lead CDM and/or clinical programmer, from
start-up through close-out. Under his leadership, Max Neeman has been providing data
management services for global studies across 60 countries at more than 100 sites globally.
‘Kotesh’ has been an integral part of developing the SOPs in Data Management and
Biostatistics and was also a key member in setting up the IT systems per ISMS (Information
Security Management System) requirements for Max Neeman’s ISO certification. He has
intimate knowledge of regulations and industry adopted data standards [such as CDISC-SDTM
and CDASH] and other associated clinical data submission deliverables; is proficient in the
understanding of regulatory requirements and expectations for clinical data systems including
21 CFR Part 11.
Koteshwar Govind at Max Neeman leads the technological Process Management/Improvement
initiatives to promote efficient and compliant best practices that are utilized for both internal
and external technologies.

3. 3
Max Neeman Process Improvement Initiative
Best Practices for Process Improvement by
Data Management Team
At Max Neeman, the Data Management team constantly
endeavors to use best practices and industry recommendations
for continuous improvement of DM processes. This ensures
high quality and quicker turnaround time.
Recently, the Max Neeman DM team undertook an
improvement project on ‘Discrepancy Identification at
Level 1’.
Quality of data is critical for the outcome of clinical trials as
they have a direct impact on human life & health. The process
of achieving the desired quality undergoes various levels of
data cleaning. Level 1 performance is directly proportional to
the time consumed in this process. An improvement in
Discrepancy Identification at Level 1 would help effectively
utilize the resources and timely completion of project.

4. 4
The Challenge
Increased Reviews
A challenge the DM team faced was that Level 1 was
identifying only approximately 60% of discrepancies over the
last 6 months, leading to an increase in number of reviews.
With the goal of identifying 80% discrepancies at Level 1, the
DM team rolled out a plan aimed at improving Max Neeman’s
data validation process.
Various recommendations were included in the system, like:
• Elaborated process flow along with a more detailed checklist
for the team
• Regular trainings and assessments on current process
• Defining quality benchmarks for all processes
• Protocol / project training to be scheduled every 3 months

5. 5
Positive Result
20% Increase
On completion of the project, improvement in the
performance of the Level 1 data cleaning increased by
approximately 20%. As a result of this positive outcome:
• The Quality benchmark was raised from 60 to 80%
• Efficiency of managers increased as there was a drastic
reduction in review time
• Better coordination among the internal teams leading to
better team work
• Level 2 output increased
• The work process became more effective as a result of the
increased quality
Although there wasn’t a direct impact on the project financially; these
improvements in the process helped us in delivering services with
improved quality at a faster pace thus leading to an exponential
increase in customer satisfaction. To conclude, the project was an
excellent quality improvement tool, which has helped us in moving
ahead with efficient and effective work processes.

6. 6
Max Neeman Data Management USPs
Max Neeman Data Management USPs
• Highly skilled human resource of 90+ employees
• Quality of work by following standards like ISO 9001, 27001
• Intuitive, User Friendly Interface for eCRF covering 60
countries across the globe
• High System Scalability
• Customized Reporting & Dashboards
• Multiple Data Extraction Formats
• Error rate of all Locked studies for Critical data item is not
more than 0.26 [acceptable error rate is <0.5]
• Medical Coding using Standard Medical Dictionaries
• MedDRA
• WHO-DD
• English speaking professionals
• Cost competitiveness
• End to End Biostatistics services for clinical trials in more
than 15 therapeutics areas across Phase I, II, III & IV
• IWRS platform available for randomization
• Expertise in CDISC legacy data conversion

7. 7
Max Neeman Data Management USPs (Continued)
PheedIT Advantages
• Full electronic CRF management
• Native SAS database structure
• Requires no client-side installation
• Transfer of database is done in Sponsor defined formats (ASCII,
SAS, and XML)
• CDISC/SDTM conversions.
• Using PheedIT, the data is directly stored in SAS format
reducing any data transfer error rate
• Validation and training services available for PheedIT
Regulatory Compliance
• Enables FDA 21 CFR part 11 compliance
• Administration of Users, Groups, User access and Study access
• Computer-generated Audit Trail
• Clinical database version handling

8. 8
The Road to Quality Clinical Data
Build, Train, Standardize
• Build quality into the system
• Train and educate site personnel, project team and reviewers/
auditors
• Decrease the amount of data collected
• Define the data set needed and specify requirements
• Standardize formats and procedures
• Also plan for data quality during post-marketing
• Decrease the number of times data are ‘handled’

9. 9
The Road to Quality Clinical Data
Tools to Ensure Data Quality
• 21 CFR Part 11, compliant system
• ISO 27001:2005 Certification for Information Security
Management System (ISMS)
• Well Laid out SOPs
• A dedicated Quality Assurance team of qualified and
experienced personnel to ensure and implements quality
standards
• Our systems undergo regular audits by various sponsors &
external quality assurance team.
• The project activities are system oriented rather than person
specific outputs. This also ensures high quality standards
and uniformity of clinical trial conduct.
• Regular trainings on SOPs, ICHE6 and other applicable
regulatory guidelines

10. 10
Positive Feedback
Highly Professional, High Quality Service
Some positive feedback received from clients for DM services:
“Max Neeman has provided a highly professional service, of
very high quality. I would classify all three items below as
excellent (Understanding the requirements, Quality of
deliverables, Responsiveness)”
“It has been a great work experience and mutual learning with
MNI. I would really like to appreciate the team work and
importance provided in adherence to timelines. I have
interacted with Devyani for all my projects. She has to be
appreciated for her hard work, sincerity and adherence to
details. Even with critical timelines the deliverables were
shared as expected by her. All services were delivered
satisfactorily”
*References available upon request and Data Management services are provided
as a stand-alone service or in addition to site management/monitoring.

11. 11
To Learn More
Contact Information:
Ann Vawter
Director, Business & Marketing
Max Neeman International
117 Edinburgh South Dr., Ste 105
Cary, NC 27511
P: 919.424.3332 / F: 919.852.5574
E: ann.vawter@neeman-medical.com
www.neeman-medical.com