CASE STUDY
The Customer
RA Chem Pharma Limited is a vertically integrated pharmaceutical company. Over the
past 10+years, it has expanded its spectrum by establishing state-of-the-art
manufacturing facilities in API, Formulations and Clinical Research.
RA Chem Pharma was built with a focused, long-term philosophy
 Total Quality: Unwavering commitment to quality in all aspects.
 Respect: Respect for our customers, partners, investors and competitors.
 Integrity: Strong principles of transparency and upright business ethics form the
cornerstone of the organization.
RA Chem Pharma is committed towards a common goal of total customer satisfaction
and confidence by providing end to end services to all the clients by continually
improving Quality Management System in accordance with cGMP, other regulatory and
statutory guidelines.
Problem


Traditional and tedious process
for managing records.
Space Crunch.
Solution
Iron Mountain’s Records &
Information Management Solution
The Value
Value
Maintaining the accuracy and adequacy of clinical research documentation is both a
critical component of Good Clinical Practice and a challenge in today’s rapidly
changing clinical research environment.

The Principal Investigator (PI) is responsible for the accuracy, completeness and
security of the records while the trial is being conducted and for meeting the required
government-regulated retention period.
Understanding the big picture of how essential study documents impact the approval
and ethics of a clinical research trial, RA Chem Pharma decided to onboard a Partner
who can protect their core business by protecting their critical information.
Iron Mountain was a perfect fit to the Customers requirement as we adhere to the
guidelines for managing clinical research records.
With an established, consistent records management program from Iron
Mountain now in place, the customer has improved process efficiencies and
enable immediate access to its critical information.
In addition, with Iron Mountain Connect in place, The Customer is ensured that
they can manage their records in a compliant manner. “We have realized a
significant reduction in the time and cost associated with storing and
retrieving records”, says Borsha Deuri, Incharge Quality


Gained systematic and highly
accountable information
management process required
for business continuity.
Timely retrievals.
Adherence to all regulatory
requirements.
We have enhanced disaster
preparedness and
maximizing the value of
information by moving data
offsite to a safe and secure
location of Iron Mountain.
A Kiran Kumar
Head Operation
CRO Division