Calyx RIM is a proven, cloud-based regulatory information system for optimizing regulatory publishing, submissions, and registrations.
Calyx RIM is a proven, cloud-based regulatory information system for optimizing regulatory publishing, submissions, and registrations.
Uniquely combining innovative cloud technology with decades of regulatory and user experience, Calyx delivers a scalable and flexible RIM solution that addresses the full complexity of today’s regulatory environment.
Designed by regulatory experts and proven across over 1 million global submissions to date, Calyx RIM is a regulatory solution you can rely on.
Uniquely combining innovative cloud technology with decades of regulatory and user experience, Calyx delivers a scalable and flexible RIM solution that addresses the full complexity of today’s regulatory environment.
Designed by regulatory experts and proven across over 1 million global submissions to date, Calyx RIM is a regulatory solution you can rely on.
With nearly 20 years of experience in regulatory compliance, Calyx’s industry-leading Regulatory Information RIM system will help ensure you meet regulatory requirements worldwide.
Calyx RIM gives users confidence in their ability to centrally plan, manage, and track product information, registrations, and authorizations throughout the life of each product. Built specifically to drive regulatory compliance, Calyx RIM streamlines regulatory affairs processes, giving users comprehensive oversight of product registration portfolios in a single location.
The market-leading RIM solution, Calyx RIM increases global coordination and collaboration between departments and affiliates by sharing a common authoritative information source and enabling users to manage projects that span multiple applications.
With IDMP standards incorporated directly into Calyx RIM, pharmaceutical companies absorb the IDMP data as part of their daily processes, ensuring compliance with emerging requirements.
Calyx RIM provides comprehensive and scalable submission publishing solutions that are suitable for operations of all sizes and produce output that is compliant with regulatory agency requirements.
It has easy-to-use submission assembly controls with components designed specifically for the capture and management of eCTD metadata. Submission assembly templates are provided and maintained by Calyx for both eCTD and non-eCTD formats. Workflow capabilities support users through multiple activities, with dependencies and defined pre-set fields that guide processes within the system.
Regulatory submissions can be complicated, time-consuming, and subject to non-compliance. Take the worry out of your submissions with Calyx RIM. And focus on getting new treatments to market.
With nearly 20 years of experience in regulatory compliance, Calyx’s industry-leading Regulatory Information RIM system will help ensure you meet regulatory requirements worldwide.
Calyx RIM gives users confidence in their ability to centrally plan, manage, and track product information, registrations, and authorizations throughout the life of each product. Built specifically to drive regulatory compliance, Calyx RIM streamlines regulatory affairs processes, giving users comprehensive oversight of product registration portfolios in a single location.
The market-leading RIM solution, Calyx RIM increases global coordination and collaboration between departments and affiliates by sharing a common authoritative information source and enabling users to manage projects that span multiple applications.
With IDMP standards incorporated directly into Calyx RIM, pharmaceutical companies absorb the IDMP data as part of their daily processes, ensuring compliance with emerging requirements.
Calyx RIM provides comprehensive and scalable submission publishing solutions that are suitable for operations of all sizes and produce output that is compliant with regulatory agency requirements.
It has easy-to-use submission assembly controls with components designed specifically for the capture and management of eCTD metadata. Submission assembly templates are provided and maintained by Calyx for both eCTD and non-eCTD formats. Workflow capabilities support users through multiple activities, with dependencies and defined pre-set fields that guide processes within the system.
Regulatory submissions can be complicated, time-consuming, and subject to non-compliance. Take the worry out of your submissions with Calyx RIM. And focus on getting new treatments to market.
Calyx delivers not only the advanced technology, but also the expertise of our people and proven processes that have helped worldwide pharmaceutical companies streamline regulatory affairs processes time and time again.
Calyx delivers not only the advanced technology, but also the expertise of our people and proven processes that have helped worldwide pharmaceutical companies streamline regulatory affairs processes time and time again.
Calyx RIM Select is an in-house regulatory publishing tool that meets the requirements of smaller organizations that complete fewer annual submissions than larger enterprises.
With the foundation of Calyx’s proven RIM system and including the technical consulting of Calyx regulatory experts, Calyx RIM Select is designed to give smaller organizations confidence in the quality of their important submissions and the scalability needed to meet the company’s growing needs.
Calyx RIM Select offers:
Calyx RIM Select is an in-house regulatory publishing tool that meets the requirements of smaller organizations that complete fewer annual submissions than larger enterprises.
With the foundation of Calyx’s proven RIM system and including the technical consulting of Calyx regulatory experts, Calyx RIM Select is designed to give smaller organizations confidence in the quality of their important submissions and the scalability needed to meet the company’s growing needs.
Calyx RIM Select offers:
Just as regulatory compliance is a fact of life in our industry, so too is constant change in regulatory requirements. Rely on Calyx RIM to keep you up-date.
Strong, controlled regulatory information is key to IDMP. Equally important is the careful planning and coordination that must take place across many internal functions and external partners in order to adopt these standards.
With nearly 100 collective years’ experience in regulatory operations and compliance, trust Calyx regulatory consulting to give you confidence in your IDMP preparation and compliance strategy.
Future health authority requirements will focus on structured data reporting. Life sciences companies need to focus their attention on this key area. It’s essential to work with a regulatory information management system that’s built on an understanding of regulatory complexities and is continually updated to reflect the evolving worldwide regulatory arena.
Rely on Calyx RIM to steer you through the evolving requirements that will impact your regulatory publishing processes, allowing you to concentrate on getting drugs to market.
Calyx RIM leverages Microsoft’s Azure-native, cloud technology to improve regulatory efficiencies while ensuring patient safety. Through automated components and cutting-edge microservices, rapid upgrades are delivered directly to your environment, giving you confidence in your regulatory compliance at all times.
And Calyx RIM streamlines the time it takes to do common activities; removing mundane tasks and allowing your experts to focus on improving patients’ lives.
With a depth and breadth of regulatory experience unmatched in the industry, Calyx’s Regulatory Consultants are routinely trusted by worldwide pharmaceutical companies for support in maneuvering the nuances of the global regulatory landscape.
Rely on our team to help you optimize regulatory processes, meet constantly evolving requirements critical to maintaining product registrations, and keep your products on the market for patients around the world.
With a depth and breadth of regulatory experience unmatched in the industry, Calyx’s Regulatory Consultants are routinely trusted by worldwide pharmaceutical companies for support in maneuvering the nuances of the global regulatory landscape.
Rely on our team to help you optimize regulatory processes, meet constantly evolving requirements critical to maintaining product registrations, and keep your products on the market for patients around the world.
To: Calyx
From: Top 5 Pharmaceutical Company
Subject: Calyx Medical Imaging helps get patients treated quickly
A very big thank you to Calyx Medical Imaging who worked outside of their turnaround timelines to review the scans that ultimately allowed the central team to approve enrollment to facilitate treatment of this patient as quickly as possible. This is a true testament of our values in ensuring that we get treatment as quickly as possible to patients that are in need.
To: Calyx
From: Top 5 Pharmaceutical Company
Subject: IRT team are great collaborators
I’m very happy with the collaboration we have seen with Calyx’s IRT team, their open communication, and their ability to discuss and solve issues.
To: Calyx
From: Top 5 Pharmaceutical Company
Subject: Calyx Medical Imaging Made this Approval Possible
A big thank you to the Calyx Medical Imaging team. This (approval) is also your accomplishment, and you should be very proud of the work you have done to make this possible. More approvals to come!
– Global Trial Manager
Liver Cancer Development Program
TO: Calyx
FROM: Veralox
SUBJECT: Calyx Medical Imaging – Thank you for meeting tight timelines
I am very impressed with the Calyx Medical Imaging team who have been incredible collaborators in helping us to advance our lead program. We especially appreciate the team working on tight timelines to help us meet our study start initiation goals. Given that we are a small company, we rely on our collaborators, and the team at Calyx works seamlessly beside us to help us advance our development programs. I look forward to continuing our partnership!
– Alicia Herr, PMP,
Veralox Therapeutics
To: Calyx
From: Top 5 Pharmaceutical Company
Subject: Calyx Medical Imaging – Transparent, Constant Collaboration
We worked very closely with Calyx on the pivotal uterine fibroid studies. Critical components of success included transparent constant collaboration with real-time communication at all levels between our study team and Calyx. This kind of communication throughout the life of the study helped to ensure our team had the information needed to make timely informed decisions and to deliver quality data for our deliverables. We were able to establish lessons learned from prior studies and implement those on this study. I’m looking forward to continuing our work together as we strive to bring more treatment options to women.
To: Calyx
From: Arrivent
Subject: Global Oncology Program – Calyx Medical Imaging Head and Shoulders above the Rest
I am writing to give testimony to the expert independent central imaging review services provided by Calyx in support of two of ArriVent’s global clinical oncology studies. Calyx has deep technical expertise in various tumor response criteria, imaging modalities, image collection logistics, data management and regulatory requirements. They gave ArriVent invaluable advice during protocol and charter development. This is coupled with a team of world-class highly specialized independent radiologists, imaging scientists, project managers, medical writers, a very efficient budget and contract group as well as superb internal processes and systems all of which contributed to a very smooth program kick-off for our lead molecule.
We have interviewed a number of different imaging CROs and Calyx is definitely head and shoulder above the others.
– Morgan Lam
SVP, Development Operations & Business Management,
Arrivent Biopharma
To: Calyx
From: Top 3 Pharmaceutical Company
Subject: Thank you Calyx Medical Imaging – Osteoporosis Trial Success
I would like to thank the Calyx Team very much for your contribution to this wonderful study outcome. Without you this marketing authorization would have never been possible.
-Medical Lead, Osteoporotic Trial,
Top 3 Pharmaceutical Company
To: Calyx
From: ProTrials
Subject: Pleased to partner with Calyx
We’re pleased to partner with Calyx and are confident that our customers will benefit from the scientific, medical, and clinical expertise they have honed during their 30 years of delivering reliable eClinical solutions to the clinical development industry.
– Christy Meyer
Director, Quality Insurance,
To: Calyx
From: LG Chem
Subject: Calyx IRT – Simplifying Complicated Randomization
I sincerely appreciate your cooperation and Calyx’s team effort for our program.
We could not have successfully completed the IRT development for both Ph3 studies without Calyx’s team expertise.
As you know, our Ph3 studies are very complex and your high degree of experience, knowledge and system (platform) were required in order to develop the IRT we wanted. Also, there were some challenges and concerns due to protocol amendment by LGC during IRT development.
But, we relied heavily on Calyx’s expertise in IRT to deliver these two complex trials in our Gout program. Calyx made recommendations on how to overcome some of the challenged we were facing, and it resulted in a solution that perfectly meets our needs.
I have been working for 13 years in clinical development area in pharmaceutical industry. Even if my experience was relatively short, I can tell that Calyx’s platform is very valid and elaborate compared to other IRT systems.
Thank you so much.
– Younghwan Jang,
Study Lead,
LG Chem, Ltd.
To: Calyx
From: ClinChoice
Subject: Partnering with Calyx for reliable data outcomes
We chose to partner with Calyx due to their tenured scientific, medical, and technical teams who possess a depth and diversity of experience in providing reliable data outcomes.
– Tiepu Liu, President,
Global Biometrics,
ClinChoice
