Case Studies Linical uses Qualio to streamline CRO efforts and help biotech and pharma companies secure regulatory approval

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	Linical uses Qualio to streamline CRO efforts and help biotech and pharma companies secure regulatory approval

Linical uses Qualio to streamline CRO efforts and help biotech and pharma companies secure regulatory approval

Technology Category	Application Infrastructure & Middleware - Data Exchange & Integration Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries	Life Sciences Pharmaceuticals
Applicable Functions	Business Operation Quality Assurance
Use Cases	Regulatory Compliance Monitoring
Services	System Integration Training
Challenge	As pharmaceutical and biotech companies scale, there eventually comes a time when managing processes like documentation using paper-based, home-grown systems becomes impossible. This is precisely the position Linical found itself in a few years ago when it merged with fellow CRO Accelovance to grow its global footprint. Read More
About Customer	Linical is a global contract research organization (CRO) that provides expertise to pharmaceutical and biotech companies to help them bring drug therapies from the development stage through the clinical trial and regulatory approval processes. The company, which was founded in 2005 and is headquartered in Japan, focuses the bulk of its work on oncology, infectious disease, and CNS research. Read More
Solution	As it happened, Accelovance had the foresight to implement and use Qualio as an enterprise quality management system (eQMS). After the unification took place, Linical examined Qualio themselves, liked what they saw, and decided to implement the solution across the entire organization. In particular, Linical was looking for an eQMS that was easy to use, easy to maintain, familiar to the market and cost-effective. Qualio checked all the boxes. At this time, Linical has more than 950 global users on Qualio, and more users are added as the company continues to scale. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - Data Exchange & Integration

Functional Applications - Enterprise Resource Planning Systems (ERP)

Applicable Industries

Life Sciences

Pharmaceuticals

Applicable Functions

Business Operation

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Services

System Integration

Training

Challenge

As pharmaceutical and biotech companies scale, there eventually comes a time when managing processes like documentation using paper-based, home-grown systems becomes impossible. This is precisely the position Linical found itself in a few years ago when it merged with fellow CRO Accelovance to grow its global footprint.

About Customer

Linical is a global contract research organization (CRO) that provides expertise to pharmaceutical and biotech companies to help them bring drug therapies from the development stage through the clinical trial and regulatory approval processes. The company, which was founded in 2005 and is headquartered in Japan, focuses the bulk of its work on oncology, infectious disease, and CNS research.

Solution

As it happened, Accelovance had the foresight to implement and use Qualio as an enterprise quality management system (eQMS). After the unification took place, Linical examined Qualio themselves, liked what they saw, and decided to implement the solution across the entire organization. In particular, Linical was looking for an eQMS that was easy to use, easy to maintain, familiar to the market and cost-effective. Qualio checked all the boxes. At this time, Linical has more than 950 global users on Qualio, and more users are added as the company continues to scale.

Impact #1	Quick deployment: Having deployed larger solutions at bigger global organizations in the past, Cochran is used to QMS platforms that take a long time to implement and an even longer time for users to get up to speed on. The experience has been completely different with Qualio, which he and his team find easy to use.
Impact #2	Streamlined document management: Cochran’s team was able to quickly learn how to operate the system, manipulate documents, and send them for approval in what’s become a quick, repeatable cycle. Qualio does not impede the process in any way.
Impact #3	Audit support: When it comes to passing internal or external audits, Qualio shines due to its ease and simplicity. One of the main ways Qualio speeds up this process is through hyperlinks, which weren’t found in the other QMS solutions Cochran used in the past.

Impact #1

Quick deployment: Having deployed larger solutions at bigger global organizations in the past, Cochran is used to QMS platforms that take a long time to implement and an even longer time for users to get up to speed on. The experience has been completely different with Qualio, which he and his team find easy to use.

Impact #2

Streamlined document management: Cochran’s team was able to quickly learn how to operate the system, manipulate documents, and send them for approval in what’s become a quick, repeatable cycle. Qualio does not impede the process in any way.

Impact #3

Audit support: When it comes to passing internal or external audits, Qualio shines due to its ease and simplicity. One of the main ways Qualio speeds up this process is through hyperlinks, which weren’t found in the other QMS solutions Cochran used in the past.

Benefit #1	Linical has more than 950 global users on Qualio.

Benefit #1

Linical has more than 950 global users on Qualio.

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Overview

Linical uses Qualio to streamline CRO efforts and help biotech and pharma companies secure regulatory approval

Operational Impact

Quantitative Benefit