- PointCross releases UBIS – Unified Business Information Services (UBIS™) - A Secure Business Email and Information Management System for Enterprises.
November, 2007 - PointCross releases Pre-Clinical study Lifecycle and Data Management Suite (PC-LDM™) for multi-party environments.
October 4, 2007 - FDA Announces SEND Pilot Project
October 3, 2007 -
CIO 100 - Awarded to Raja Ramesh, PointCross - The Innovative 2007
- High Resolution Pdf
September 7, 2007
PharmQuest is now a part of PointCross.
Our website is being updated following our merger with PharmQuest and release of new products.
SEND-IT™ - A Business Ready Offering from PointCross for your SEND initiatives
SEND-IT™ is the only end-to-end business ready solution available in the industry today to create, visualize and deliver SEND compliant pre-clinical datasets as part of regulatory submissions to the FDA.
SEND-IT streamlines the operational exchange of pre-clinical information between CROs and sponsors in SEND or other data-centric formats leading to significant cost and time savings.
SEND-IT is offered by PointCross - the only CDISC Registered Solution Provider for SEND solutions – and its authorized partners.
SEND-IT solutions are configured on top of PointCross’ proven Orchestra technology platform, and are optionally available as part of our broader Pre-Clinical Lifecycle and Data Management offering.
We offer our SEND-IT solutions directly on a firm fixed price basis.
Business Benefits of SEND-IT™
- Allows extraction of datasets from your existing data acquisition systems in a vendor neutral XML “operational data model” together with audit traceability; this is accomplished using our Semantic Data Exchange (SDE™) technology
- Provides the ability to publish data into SEND format, and validate the package using our proprietary SEND Validator™
- Allows you to ‘have the eyes’ of the FDA by using ToxVision for data visualization and review prior to submitting your datasets; ToxVision can also be used by your scientists to configure custom views to further explore toxicology datasets
- Allows easy updates to the SEND data models and validation schema
- Accelerates your drug development pipeline by automating & streamlining submissions
- Reduces errors caused by tedious manual processes of data re-entry
- Allows for data mining and data warehousing capabilities
- Provides a clear strategic roadmap for streamlining interface management, and secure data exchange between sponsors and CROs, and between sponsors and the FDA
SEND-IT™: Architecture and Solution Offerings
PointCross now provides an end-to-end business ready SEND solution framework shown in the figure above, and supported by PointCross’ professional services team, to meet your needs of complying with regulatory submission guidelines.
Global Support and Delivery
SEND-IT is supported by:
- SEND experts who have been involved with this data standards initiative from its inception
- Completely validated processes
- Globally accessible technical personnel and help desks
- Ability to rapidly mobilize resources globally to support your needs
- A global network of systems integration and staffing firms
Our SEND Assurance
Join us in supporting this important Agency and industry supported initiative by becoming SEND capable now.
You will have peace of mind knowing that your costs will be contained, that you will be SEND-enabled, and ready to submit soon after changes to the SEND standards are completed.
You can also rest assured that any changes to the submission standards during the course of the regulatory pilot are included, enabling you to keep up-to-date with the latest changes in data standards.
Benefit by being Proactive
The FDA sees the SEND initiative as part of a vital program intended to to bring new discoveries to the public more quickly, efficiently and safely.
Join other leading companies by speaking with us today.
Our cutting edge technology solutions have been developed with inputs from the industry and the FDA.
We can help you realize operational efficiencies while supporting the FDA in its quest to overcome the challenges of managing vast amounts of critical information.
Pricing Options to Fit Your Needs
PointCross offers a flexible set of engagement options designed to fit to your specific needs.
We provide simple fixed price quotes for use of our solutions or services. This reduces your risks and helps with your internal planning and budgeting requirements.
Submission-Based Pricing
- A fixed price per study pricing model for your submissions. PointCross will prepare and securely deliver SEND ready datasets to you.
- At any time, you can switch to a subscription-based model, if desired.
Subscription-Based Model
- You can choose to either deploy our solutions in your environment, or opt for a SaaS (Software-as-a-Service) model and access our technology offerings in a secure hosted facility. For both of these models, our expectation is that you will be responsible for preparation of your own datasets for submission.
- We will provide you with flexible options to either use our entire stack of SEND-IT offerings, or subscribe to individual components like the SEND Validator and/or ToxVision.
Schedule Your Business Ready SEND Analysis Today
We will first assess your environment, source systems and/or dataset examples, and your specific study needs.
We will then provide you with a fixed price quote that will outline what we will deliver to make your SEND initiative business and submission ready.
To discuss your options, please contact us at:
Email: SENDIT@pointcross.com
Call: +1 (650) 350-1900