Max Neeman International is India’s leading contract research organization providing full range of clinical development services to small, mid-size and global pharmaceutical, biotech and medical device companies.

1. “Road
To
Quality
Clinical
Trials”
Dr.
Nilu
Bha,a,
Manager
Quality
Assurance
A JSS Medical Research Company

2. 2
Road To Quality Clinical Trials
Quality Policy
Max Neeman International is committed to providing quality
services to both external and internal customers. We ensure
this by using robust quality matrices. We shall continually
strive to achieve it by benchmarking all our processes
against global quality standards.
‘Max Neeman’ undertakes a number of quality initiatives,
including ISO certifications and internal audits to ensure that
it is following standardized internal processes and best
practices in the organization.
Being in a quality driven industry we follow a robust system
of quality control processes and all our operational activities
are governed by strict adherence to ICH-GCP guidelines,
local regulations and well laid out SOPs.

3. 3
Tools To Ensure Quality
q Build quality into the system
q 21 CFR Part 11, compliant system
q ISO Certifications for Site Management, Monitoring & Clinical Data
Management, Information Security Management System (ISMS) &
Clinical Investigational relating to Medical Devices
q Well Laid out SOPs
q Train and educate site personnel, project team and reviewers / auditors
q A dedicated Quality Assurance team of qualified and experienced
personnel to ensure and implements quality standards
q Regular compliance audits
q System oriented project execution plan - ensures high quality standards
and uniformity of clinical trial conduct
q Continuous trainings on SOPs, ICH-GCP(E6) and other applicable
regulatory guidelines
q Standardize formats and procedures

4. 4
5 Steps of Continuous Quality Management
Plan &
Prioritize
Control &
Report
MonitorIdentify
Analyze

5. 5
Work Environment and Robust SOPs
q Promote high quality work environment by:
q Establishing and deploying work systems through well-defined SOPs
q Adherence to ISO systems and processes
q Empowering QA department to conduct internal audits based on
approved quarterly plans
q Acting upon QA observations in weekly & monthly meetings
q Robust SOPs
q We place great emphasis on developing SOPs and updating them at
frequent intervals to ensure quality and service excellence to all our
customers. The QA department, with the help of respective SBUs,
develop SOPs to standardize the quality of work. These SOPs are then
reviewed annually depending upon the latest development and
feedback from respective departments/customers.
q The SOPs have been carefully drafted within the boundaries of ICH E6,
applicable regulatory guidelines and the detailed steps involved in the
conduct of a Clinical Trial across all Phases (Phase I to IV)

6. 6
International Quality Certifications
q Quality Management System: ISO 9001: 2008 -
ISO 9001:2008 sets out the criteria for a quality management
system and is based on quality management principles including
a strong customer focus, process oriented approach and
continual improvement. ISO 9001 helped us to ensure that all
our customers get consistent, good quality services through the
life cycle.
q Information Security Management System: ISO 27001:2005 -
ISO 27001:2005 specifies the requirements for high quality
GCP-compliant data management. It also specifies the
requirements for the implementation of security controls to
ensure data security and compliance. ISO 27001:2005 is
designed to ensure the selection of adequate and proportionate
security controls that helps protect information assets and give
confidence to customers.

7. 7
International Quality Certifications (continued)
q Management System for Clinical Investigational plan
relating to Medical Devices: ISO 14155: 2011 -
ISO 14155:2011 specifies general requirements intended to protect
the rights, safety and well-being of human subjects, ensure the scientific
conduct of the clinical investigation and the credibility of the results,
define the responsibilities of the sponsor and principal investigator, and
assist sponsors, investigators, ethics committees, regulatory authorities
and other bodies involved in the conformity assessment of medical
devices.
q Assessed for Malcolm Baldrige Performance Excellence Program -
Malcolm Baldrige was designed to raise awareness of quality
management and recognize the companies that have successfully
implemented Quality Management Systems. Malcolm Baldrige Provides a
set of criteria to improve performance by focusing on two goals: delivering
value to customers and improving the organization’s overall performance.

8. 8
MNI Therapeutic ExperienceTypes&of&Audit& Number&To&Date&
USFDA&&Audits& 8&
DCGI&Audits& 6&
Client&Audits& 83&
System&Audits& 16/Year&
Finance&Audits& 1&half&Yearly&
&
Max Neeman Audits

9. 9
Quality Framework
*Indian Council of Medical Research

10. 10
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