Vita Data Sciences to Host CDISC Public Training Led by Authorized Instructors in Waltham Office
WALTHAM, MA – Vita Data Sciences, the dedicated life sciences professional services division of Softworld, Inc., will be hosting CDISC Public Training the week of September 17th, 2018. These training sessions will be led by authorized CDISC instructors and will cover a variety of topics. The schedule of courses is as follows: September 17-18; 9:00 am – 5:00 pm Name: 2-day SDTM Theory and Application Instructor: Sarah McLaughlin Course Language: English September 20; 1:00 pm – 5:00 pm Name: 1/2-day ADaM Primer Instructor: Richann Watson Course Language: English September 21; 9:00 am – 5:00 pm Name: 1 day ADaM Theory and Application Instructor: Richann Watson Course Language: English If you are interested in registering for any of the above events, please see the full details here. ABOUT THE ORGANIZATIONS CDISC is a 501(c)(3) global nonprofit organization that develops data standards to foster smarter research and enable connections to healthcare. CDISC standards allow data to speak the same language, by providing common formats for data collection, data sharing, and data analyses to make the most of the valuable information offered by patients participating in research studies around the globe, enabling researchers…
Quality Check your CDISC Data Submission Folder Before It Is Too Late!
This paper provides an overview of a SAS®-based tool to perform a final quality check on your CDISC data submission package which are not typically covered by either an existing CDISC datasets compliance tools or by commercially available eCTD publishing software. To download this white paper, please submit the form below and we will e-mail you the link.
Importance of Niche Provider for Successful NDA Submission: Rescue Case Study
This paper outlines significant gaps identified in the deliverables provided by an outsourced full-service CRO, services offered to the Sponsor and lessons learnt through a case study on how the quality expectations and submission timelines were met. To download this white paper, please submit the form below and we will e-mail you the link.
Consider Define.xml Generation during Development of CDISC Dataset Mapping Specifications
This paper not only presents an approach to create the define.xml during SDTM specification and dataset development phase but also provides insights on how to use Pinnacle21 validator as a tool during the SDTM development lifecycle. To download this white paper, please submit the form below and we will e-mail you the link.
Lead Programmer Needs Help: Dedicated Programming Project Manager to the Rescue!
This paper describes the distinct roles of a Lead Programmer and a Programming Project Manager, and the importance of having both for successful management of the study deliverables and the resources. To download this white paper, please submit the form below and we will e-mail you the link.
Building Efficiency and Quality in SDTM Development Cycle
This paper helps the programmer to understand the compliance requirements upfront and implement those during SDTM mapping specifications development. To download the this white paper, please submit the form below and we will e-mail you the link.
Niche Provider for Successful NDA Submissions
This case study outlines a project where VDS, as a niche provider, worked with a Sponsor towards their final NDA submission packet, even though the Sponsor had outsourced these services to a global full-service CRO. To download this case study, please submit the form below and we will e-mail you the link.
For SDTM mapping, Protocol and CRF will serve as the initial supporting document. Database schema along with sample data if available will aid in better understanding of the database structure which will give clarity in mapping and defining specification. Annotated CRF (aCRF) will be created against the blank CRF which will map the fields in the CRF against the SDTM domains. Trial Design Model Domains (TDM) will also be developed in parallel in the initial stage itself. SDTM specification will be developed against the aCRF to map the raw data into SDTM domains specifying the characteristics of each and every variable for all the applicable SDTM domains. According to this Specification along with the support of aCRF and TDM the programmer will start the programming of SDTM domains. Define.xml for SDTM will be created after the finalization of aCRF, SDTM specifications and SDTM datasets. For the mapping of ADaM domains, Statistical Analysis Plan (SAP) will also be required. Against the finalized SAP and SDTM datasets the ADaM specification will be created. After the completion of ADaM specification programmer will start working on the generation of ADaM dataset. When both ADaM…
Experience the Vita Data Sciences difference – Visit us at PharmaSUG!
Vita Data Sciences is excited to participate at PharmaSUG 2017 from May 14 – May 17, 2017 in Baltimore, MD. Vita Data Sciences is always looking to build relationships with life sciences thought leaders for long-term professional partnerships. Our team of highly skilled and experienced data scientists and analysts are passionate about innovating customized clinical data strategies and solutions for our biotech, pharmaceutical and medical device clients. Stop in to Booth #313. Say Hello Experience the Vita Data difference for yourself! Presentations Vita Data Sciences featured speakers will deliver the following conference presentations: Title: Lead Programmer Needs Help: Dedicated Programming Project Manager to the Rescue! Authors: Gloria Boye, Aparna Poona & Bhavin Busa Section: Management and Support Title: Quality Check your CDISC Data Submission Folder Before It Is Too Late! Author: Bhavin Busa Section: Submission Standards Poker Night Event Who says industry conferences can’t be both informative andfun? Not Vita Data Sciences! We’re hosting a PharmaSUG Texas Hold’em Tournament on Monday, May 15, 2017 at 7:30pm in the Holiday Ballroom of the conference hotel. Participants will be served refreshments and play for prizes (gift cards). Signup in advance so you…