openPR Logo
Press release

Xybion Announces a Transformative Technology, Services and Artificial Intelligence Bundle, 'SEND Intelligence Service', for SENDIG v3.1

09-18-2018 02:36 PM CET | IT, New Media & Software

Press release from: Xybion Corporation

Savante

Savante

Considering the sense of urgency to meet SENDIG 3.1 deadline and the need to improve data capture, data processing and report efficiently, Xybion, a US-based global technology-enabled business solutions provider for companies operating in the highly regulated industries, announced today that it has launched “SEND Intelligence Service” for SEND IG v3.0 and v3.1. This is a fully integrated technology and service bundle offer that will help CRO and sponsor companies simplify processes, capture data right and identify data issues automatically for SEND ready dataset right the first time.

Beginning March 15, 2019, all the Life Sciences Organizations must align their nonclinical datasets with SENDIG 3.1 (Standard for Exchange of Nonclinical Data). However, as per the PhUSE 2018 report, over 41% of Life Sciences Organizations are either not ready for SENDIG v3.1 or intend to have ad-hoc strategies for SENDIG v3.1 submissions. Nearly half the time, the sponsor organizations are facing issues while exchanging and consolidating SEND data with the CROs. Companies that are SENDIG ready are facing significant data challenges resulting in submission delays and a large consulting spend to make data reportable.

With the introduction of Labwise™ and the upgraded version of Savante™ that works seamlessly with Pristima® and other pre-clinical data management solutions, Xybion established a right solution for Life Sciences Organizations to streamline their nonclinical datasets in compliance with the latest standards of CDISC-SEND submissions. In the recent years, Xybion’s has produced over 1000 SEND v3.0 submissions. Now, it’s fully integrated, automated and intelligent products and services will produce both v3.0 for on-going studies and v3.1-compliant datasets for studies that run in any pre-clinical systems.

Kamal Biswas, President and COO of Xybion said “The SEND-as-a-service business has been an exciting growth opportunity for Xybion. From my consulting experience, I could understand that the industry needed to solve this problem by combining technology and services together. The early automated detection and correction of data issues can make the process much more efficient, error-free, cost-effective and significantly reduce data integrity issues. We thank our client community which provided detailed guidance and assistance throughout the six-month beta testing period that led up to the release; this beta program was invaluable and assures the functionality and quality datasets to be submitted to the FDA.”

Xybion offers SEND-related services to the companies looking to improve their current operations and companies with limited expertise or SEND utilities in-house. Carlos Frade, VP of Pre-clinical R&D Solutions, stated “For those clients who conduct preclinical studies without the use of Pristima, or who utilize CROs that do not provide SEND-compliant submission datasets, Xybion can provide this expertise immediately and cost-effectively. Our arsenal of tools has been greatly expanded with this release.”

Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries. Our unique solutions focus on regulatory compliance, GRC, quality management, GLP, integrated preclinical lab management, early-stage drug discovery, content migration and systems validation. Xybion specializes in helping companies improve their overall compliance processes and provides a complete view and prediction of organizational risk across various global operating models.

Xybion's combination of software, business process management and related services enables us to cover a broad spectrum of critical business needs for companies and we deliver our solutions on a global scale. Since its founding in 1977, Xybion Corporation has supported over 100 clients, through software, services and consulting, including all of the top 20 global life sciences companies. Our leadership in this dynamic and ever-changing industry has been a cornerstone of our high-value reputation.

2000 Lenox Dr
Lawrenceville, NJ 08648

This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release Xybion Announces a Transformative Technology, Services and Artificial Intelligence Bundle, 'SEND Intelligence Service', for SENDIG v3.1 here

News-ID: 1243731 • Views:

More Releases from Xybion Corporation

Xybion Announces a Transformative Technology, Services and Artificial Intelligence Bundle, 'SEND Intelligence Service', for SENDIG v3.1
Xybion Announces a Transformative Technology, Services and Artificial Intelligen …
Considering the sense of urgency to meet SENDIG 3.1 deadline and the need to improve data capture, data processing and report efficiently, Xybion, a US-based global technology-enabled business solutions provider for companies operating in the highly regulated industries, announced today that it has launched “SEND Intelligence Service” for SEND IG v3.0 and v3.1. This is a fully integrated technology and service bundle offer that will help CRO and sponsor companies

More Releases for SEND

Android Users Can Finally Send ARmoji Now!
A talking dog, a winking bear and a smiling frog, all of the AR animal emoji will be launched soon at Typany Keyboard Now. When you speak, or change your eyes expression, or shake your head, the ARmoji will do the exact same. But most of all, it is very easy to share. Once you’ve created your ARmoji, it can be saved as videos in your album or directly accessible
Wireless Cellular Solutions Send Data Remotely
Save Gas—Use a Modem Data Logger! CHESTERLAND, OH—January 29, 2018 Need to record and collect data from a remote location? At CAS DataLoggers we can supply your remote monitoring application with wireless cellular dataloggers featuring integrated cellular modems. This allows for remote alarming and automatic data upload from any location where cellular service is available. Forget about having to travel out to the area to get your data! Our data loggers can schedule
Send Rakhi Abroad with Sendrakhi
New Delhi, Delhi, 13-July-17: Raksha Bandhan is going to be an International affair this year with SendRakhi.com unveiling their plans to provide online Rakhi delivery to many International countries. Online shoppers for Rakhi and Rakhi gifts had anticipated this much-awaited step by the website. This promises to solve the many problems that people face while trying to send Rakhi to the USA (https://www.sendrakhi.com/usa) or any other foreign land by themselves.
Send Rakhi to Pune via Rakhi.in
In order to help people send rakhis to Pune, rakhi.in has expanded its services. Now it’s allowing people to choose from a wide range and send rakhi online anywhere in India. New Delhi, India :- Rakhi.in a renowned online rakhi store specialized in offering rakhis and special gifts is now all set to help sisters send rakhi to Pune. The site has launched a fully-dedicated selection of rakhis for Pune
Send Love Through a Sandwich
WHAT: As the age-old saying goes, “sharing is caring,” and on Thursday, November 3rd, 2016, Pauli’s, the neighborhood sandwich shop located in Boston’s North End, is celebrating National Sandwich Day with “Send a Sandwich,” allowing customers to call ahead and pre-pay for a sandwich order to send to that special someone. Famous for their “wicked fresh” ingredients and “crazy
UK Workers Send Personal Packages From the Workplace
A recent parcel delivery industry survey has found that more UK employees are choosing to send personal parcels from their work place. The survey, which questioned 2,000 people as carried out by OnePoll, and revealed that almost a third of those people surveyed admitted to using the company mail room to send their parcels. Dawn Henderson, Marketing Executive for ParcelsPlease (http://www.parcelsplease.co.uk/ ) comments: “The research conducted by OnePoll is actually quite