News
19 July 2010
In this issue of K-news, we have a catalogue of Kit Howard’s articles from the past year, two new additions, a job opportunities section and a consultant listing. We are also bringing back our Fun Pharma Facts and hope you enjoy some great sunset pictures. For a limited time, we are also having a 2-for-1 special on every Kestrel educational webinar, please take advantage of the savings. And as always, please feel free to forward K-News to anyone who you think would enjoy it.
11 June 2010
Converging Data Challenges: How to Help the FDA
The FDA and DIA collaborated on a meeting in March on the data challenges faced by the FDA, and the role that, among other things, industry and standards play in making their actions more efficient. Kit wrote an article on the meeting and its implications for industry and standards, which was published in ClinPage. You can find it here:
(http://www.clinpage.com/article/how_to_help_fda/C9.
8 June 2010
In Kestrel’s June edition of K-News, we take a look at 10 Myths About Standards, introduce a new section called Fun Pharma Facts, break down our education information and offer some great pictures to brighten your day.
7 May 2010
The new version of CDASH standards and user guide are available for public review. Comments are due by May 14.
The May issue of K-News provides guidance on reviewing these documents.
In addition, the full downloadable, 7 Part Series of Standards Management 101 Courses will be available in July.
9 April 2010
In this month’s K-News we explore the FDA’s take on standards, along with descriptions of our upcoming webinar as well as some great pictures of spring flowers to brighten your day.
3 March 2010
In this edition of K-News, we explore the question of help text in EDC applications, we have four new innovative education webinars and some great pictures of spring flowers.
21 January 2010
The second part of Kestrel's Standards 101 is coming on January 27, and a guest webinar with Jonathon Andrus on managing your eClinical Vendors on January 25.
The FDA has also released new guidance on "DILI" that will require a lot more data for clinical trials. Read about this and more in the January issue of K-News.
4 January 2010
Registration is open for Kestrel's new education line-up, including Standards Management 101 (series starts 13 Jan 2010), and Best Practices in Designing Clinical Data (series starts 11 Jan 2010). These innovative courses provide vital information on optimizing your data standards and data quality, and you won't want to miss them. For course descriptions and to register, please visit www.kestrelconsulting.com.
17 December 2009
ISO has released a final draft of GCPs for medical devices, and Kestrel's new line up of courses is open for registration . Find out about this and more in this month's K-News.
14 September 2009
This month K-News muses about how our obsession with working in silos reduces our efficiency, and provides some suggestions for improving the situation. Course offerings for September and October are also listed.
August 2009
This issue of K-News features an article describing a talk given recently by Dr. Leslie Ball, from the FDA, in which she explores risk management for clinical data quality.
8 June 2009
The newest issue of K-News is here, with current dates for Kestrel webinars, as well as a suggestion for helping with subject recruitment.
20 March 2009
ClinPage recently featured Kestrel's Data Life Cycle Plan® methodology in an article discussing the broad applicability of CDISC standards. To view this article, please click here.
6 March 2009
The current issue of K-News which covers the updates to CDASH, the new Kestrel Webinars and other Standards topics is now available.
1 March 2009
Kestrel’s Kit Howard will be presenting at the DIA Annual Meeting, being held in San Diego from June 21 – 25. She is presenting “Strategies for Implementing Data Standards” on Tuesday June 22 at 1:30pm, as part of the CDM Track. She is also chairing a session in the CDM Track called “Minimizing Data Queries in Clinical Trials” on Thursday 25 June at 8:30 am. The session includes presentations by Kit on “How to Stop Drowning in Data Queries By Collaborating Across Roles,” by Jonathan Andrus from Phoenix Data Systems on “Using Electronic Clinical Tools to Improve Data Quality,” and by Melissa Binz from Wyeth on “Eliminating Queries by Using Data Standards.” Please join us for these informative sessions.
3 October 2008
CDISC’s CDASH data capture standards were released, marking a significant milestone in clinical research infrastructure. These standards focus on making data capture more efficient and consistent for sites, sponsors and CROs, and will result in improved efficiency, cost and quality. It is one more step in helping to bring life-saving treatment to patients in need. Kestrel is very proud to have been an active participant in developing these standards, and continues to contribute to the CDASH management team
10 March 2008
Kestrel proudly announces the development of Core Data DLPs. These documents join the power of the DLP process to the core definitions of the data most commonly used in clinical trials. CDISC-compatible, these Core DLPs offer clients a ready-made end-to-end solution for their clinical data needs.
10 February 2008
Kestrel is pleased to announce that Alec Vardy, Lynne Welling and Lori Weaver have joined our consulting network in support of Data Lifecycle Plans®.
Alec brings a wealth of statistical and data management knowledge, as well as many years of working with small biotech and start-up companies.
Lynne and Lori both have broad and in-depth experience as clinical scientists and as cross-functional project leaders. Together they add immeasurably to the expertise Kestrel brings to its clients.
November 2007
Kit Howard published an article on standardization beyond CDISC in World Pharma Network. Please see article here (http://www.worldpharmanetwork.com/, click on Archives, November 2007, Clinical Research)
Kestrel Announces Partnership with Octagon Research Solutions
At the Drug Information Association’s 43rd Annual Meeting, held in Atlanta Georgia, Kestrel and Octagon announced a new partnership to implement Kestrel’s Data Lifecycle Plans in Octagon’s ViewPoint process management software solution. This partnership will provide an electronic DLP environment that will greatly enhance the usability of the DLPs. Please see the official press release on Octagon’s website.
Kestrel Presents Paper on Risk-Based Approach to Data Quality
Kit Howard presented a session at the recent DIA Annual Meeting in Atlanta on using a risk-based approach to determining how to clean data in clinical trials. Some of this material is also being used by the DQRI Data Patterns team, which is looking at how to use pattern-detection approaches to identifying data quality issues. The slides from the presentation are available on the Resources page of this website.
An accompanying article expanding upon the slides appeared in the June issue of the Journal for Clinical Research Best Practices, and can be accessed at www.firstclinical.com/journal/2007/0706.
K-News
K-News is our newsletter that brings you information about industry, academic and government events impacting clinical data standards. We hope you find it useful and informative. Please contact us for additional information on any of the articles, and with comments, suggestions or ideas for additional content.
Please click K-News for the prior issue.
Kestrel Consultants Announces Launch of Blog.
Kestrel is pleased to announce
the launch of our new blog named K-Blog. Hosted by Google, the blog is a forum
for exploring a variety of thoughts and ideas important to data and process
standards in the clinical trials world. We hope you will find the posts interesting,
informative and stimulating. It can be found at http://kestrelconsultants.blogspot.com.