If you deliver services to life sciences companies, we get it. They demand perfection.
CROs, Labs and Services Companies
CROs, labs, and other life sciences service companies are in the business of delivering services to some of the toughest customers out there. There is no room for error. Agatha delivers robust applications that deliver essential functionality, can be put in place quickly and which can flex to meet the needs of each customer.
Supporting Clinical Operations
CROs have to deliver perfection for their customers. Sponsors expect — actually demand — that every step of every clinical trial is documented, every Trial Master File is inspection ready, and that they can report on the state of every trial at any moment.
With new clients coming on quickly, CROs need a system that can be deployed in days and tailored to the needs of each trial. One size definitely does not fit all.
Agatha’s Clinical applications provide the flexibility, scalability, and full set of documents needed to manage every aspect of the TMF process for multiple trials of diverse types. This includes the collection, management, and tracking of all TMF (and ISF) content, automated information sharing between sponsors, CROs, and sites as well as tracking and reporting on a wide range of clinical trial information, including dates, milestones, sites, stakeholders, and the status of expected documents.
Supporting Quality Processes
CROs have to deliver perfection for their customers. Sponsors expect — actually demand — that every step of every clinical trial is documented, and every Trial Master File is inspection ready. And that they can report on the state of every trial at any moment.
And with new clients coming on quickly, they need a system that can be deployed in days and tailored to the needs of each trial. One size definitely does not fit all.
Agatha’s Clinical applications provide the flexibility, the scalability and the full set of complete needed to manage every aspect of the TMF process for multiple trials of diverse types. That includes the collection, management and tracking of all TMF (and ISF) content, automated information sharing between sponsors, CROs, and sites as well as tracking and reporting on a wide range of clinical trial information, including dates, milestones, sites, stakeholders and the status of expected documents.
“Being able to provide our clients with access to the system (eTMF), they have recognized the benefit of having insight into the TMF at any time and ease of having shared responsibility for the TMF.”
Senior Director of Clinical Research
Quality / Information Security Policy
Based on our management vision, “By improving clinical research procedures with technology, we will contribute to delivering new drugs to patients as soon as possible and reducing medical costs”, by providing a content management cloud service for the pharmaceutical and medical fields (“Agatha”). We recognize that ensuring quality and information security is essential to providing services that customers can use with peace of mind. We have established a basic quality and information security policy so that all Agatha employees are highly aware of quality and information security, act accordingly, and strive for continuous improvement.
In order to meet applicable legal and regulatory requirements, customer requirements, and requirements set by the Company, we inform all applicable employees of the importance of meeting these requirements.
When providing cloud services we securely manage important information such as customers’ confidential information and personal information to prevent it from being leaked, lost, damaged, or misused. We do not disclose business-related information beyond the specified range, even among employees. In the unlikely event of a violation, the disciplinary action stipulated in the work regulations will be applied. Also, when outsourcing, we take information security into consideration.
In business activities, we respond to the needs of stakeholders and provide content management cloud services that adhere to legal, regulatory requirements, and customer requirements in a timely and accurate manner.
We set quality and information security targets in line with this policy, maintain the achieved level through activities based on the PDCA cycle, and implement continuous improvement. In implementing this policy, we inform everyone, from officers to employees, of this policy and develop the necessary knowledge and judgment through daily work, education, and training.
Responding to Changes in the External and Internal Environment
This policy is evaluated and reviewed regularly through management reviews in order to respond to changes in our management vision and social conditions. In addition, in response to changes in the area of business activities, business content, information assets handled, information and communication technology, etc., we carry out reviews of the external and internal business environment and perform regular information security risk assessments to manage quality and information security.
Enacted: December 1, 2017
Revised: June 1, 2020
Chiemi Kamakura, President and CEO of Agatha Inc.
Interested in seeing how Agatha’s applications can help you improve your clinical and quality processes? Take one for a test drive.