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Clinical Trial Management system implementation for Protech Pharmaservices Corporation (PPC)

​As a prestigious CRO of Taiwan with affiliates around Asia, PPC is dedicated to serving the pharmaceutical and biotechnology industry with a costeffective, safe and high-standard quality for clinical and non-clinical drug development, shortening the lead time to market. With the increasing demand of a fast efficiency of IT performance, higher requirements from customers for a better management of the system, PPC leadership decided to implement a clinical trial management system.
As an IT company rooted from Novo Nordisk, NNIT knows more about life science companies than the IT industry.
Based on this and after an in-depth investigation and analysis, PPC finally concluded that NNIT’s solution is the best
to optimise the operation system. In the long run, PPC expects to see improved process efficiency, a better trial quality and lower trial costs from the implementation.

The challenge

After a thorough analysis and a series of activities for PPC’s IT platform, NNIT has defined its IT challenges and barriers
clearly and has recommended solutions to manage them. In the present state, PPC’s information island is still discrete and
isolated with trials running in different teams, which have greatly lowered its efficiency.
Besides that, PPC needs close communication with sponsors to provide the desired documents on time, and within
budget. PPC is still facing slow feedback sometimes upon a sponsor’s request of a report. The lacks of a complete overview of the status of the trials in general as well as the management of assets history are still among the main concerns for their future development.
The acceleration solution was created based upon the clinical business process and business user requirements developed
by industry experts. By using these documents we are able to identify the processes that a CTMS should support and work towards to optimise the functionality of these areas.

The solution

According to PPC’s current problems and status, NNIT has created a customised solution of CTMS. With the strength of
clinical focus, project intelligence, and cost benefit, CTMS has optimised its IT functionality and improved the process
efficiency greatly. CTMS provides an application implementation and training solution as opposed to a full system
development lifecycle. It has been created to provide all of the items necessary to achieve a successful implementation in
the minimal amount of time. To address the current issues of PPC, NNIT has built up a centralised platform to collect project information which has facilitated all relevant staff to get easy access to relevant information. According to the actual business operation, we have created easy query and reporting functionality, reusable resource for process
planning and visit design, efficient electronically based trial data collecting, and real time online access to sponsors for
data analysis. NNIT also provides a comprehensive solution capable of managing information and processes from EDC, CDMS, adverse event reporting systems, and IVRS, etc.

The result

So what’s the result? NNIT’s CTMS Solution has realized a 50-85% reduction in implementation costs as compared to
standard consultation services. How does the solution work? NNIT has enabled easy transition from paper-based,
legacy clinical trial methods to all-electronic, Internet-enabled solutions and the CTMS architecture scales not only for
enterprise growth but also to accommodate multiple trials. Just as PPC expected, the time and cost of clinical process are
greatly reduced. The implementation of CTMS has helped PPC improve the productivity and throughput of clinical operations and has helped the planning and scheduling process within clinical trials, also improving analytical
abilities with the clinical data. With regard to information, the new system has served as a centralised repository for all investigators to collect and track relevant information about research, including personal profiles to disease specialties. Information will be readily available to manage clinical trials at different tiers – local, regional and global.
This new solution has improved the IT ability to closely monitor the financial activity between the enterprise and its
respective investigators, and offered a consistent view of the clinical trials undertaken by the customer and provide up to
date information on clinical trial statuses across the organization. The common platform, which NNIT has customised for
PPC, will assist the customer in conducting their activities to achieve operational efficiency. Plans are underway to integrate Siebel Clinical with the customer’s finance system. This will help streamline the business and support for real time and accurate reporting, enabling traceability and auditability, and helping reduce the risk of errors due to manually entered information.
According to our regular customer’s feedback – PPC scores us 5 which is the highest score. The customer is satisfied with both the result of the project and the performance of NNIT project delivery team.​

About PPC

PPC is one of the prestigious CRO grew up in Taiwan with local affiliates around the AsiaPacific region in Japan, China, Hong Kong, Singapore and Australia for Asian Study. The company mission is to continuously dedicate to serving the pharmaceutical and biotechnology industry with costeffective, safe and high standard quality for clinical and non-clinical drug development and shortening the lead time to market

 

 

NNIT Life Sciences+45 7024 4242nnitcontact@nnit.com ​​https://www.linkedin.com/company/nnit-it-for-life-sciences?trk=company_nameNNIT Life Sciences

 

 

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