R a pharma chem

Problem:

• Traditional and tedious process for managing records.
• Space Crunch.

Solution:

Iron Mountain’s Records & Information Management Solution

Value:

• 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 maximising the value of information by moving data offsite to a safe and secure location of Iron Mountain."

A Kiran Kumar
Head Operation
CRO Division

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 organisation.

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.

The 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 realised a significant reduction in the time and cost associated with storing and retrieving records”, says Borsha Deuri, Incharge Quality