Veristat recently participated in the United Way Holiday Program, a program that aims to help struggling families in the local Boston area. The Versistat staff has participated in this program since 2006, coming together every December to spend time with the community and offer help in any way they can.

This year, Veristat was able to assist in providing toys and clothing to 20 local children and adults. During this Holiday season, Veristat hopes to share the spirit of giving and support to those affected by our struggling economy.  If you are looking for more information about how you can help the United Way Holiday Program please contact your local branch for more information.

For more information on Veristat please email Cindy Henderson at info@veristat.com

We would like to thank everyone who stopped by our booth at this year’s DIA Conference in Chicago and for making it a successful event for our team.  It was a pleasure to meet everyone who stopped by our booth to discuss how Veristat, a full service Contract Research Organization, can support your clinical development needs.

We would also like to congratulate Ramses Sadek, winner of Veristat’s iPad2 drawing!  Congratulations Ramses; we hope you enjoy your new iPad2.

Veristat is a mid-sized Contract Research Organization and CDISC Registered Solutions Provider located just outside of Boston that has been providing services in support of clinical programs since 1994.  Veristat offers comprehensive services in biostatistics, data management, medical writing, CDISC implementations, regulatory submissions, and strategic consulting.

If you would like more information on how Veristat can support your clinical development programs and what makes us a unique CRO, please contact Bryan Adams at info@veristat.com.

Thank you again, and we hope to see you next year at DIA 2012 in Philadelphia.

Friday, July 1, 2011

Veristat, a full-service clinical research organization (CRO) with demonstrated experience in supporting clinical trials and regulatory submissions, exhibited at another successful Annual DIA Conference last week in Chicago.

There were a lot of new company names at the conference this year, reflecting the change and consolidation happening within the industry, which reminded us that having supported clinical trials for over 15 years, Veristat can claim it has been in the industry for a long-time!  Our time at DIA also made us remember that even though we are a small to midsize CRO, Veristat has large company experience having supported over 425 clinical trials and playing pivotal roles in numerous successful NDA, sNDA, and BLA submissions.

In addition, we had a lot of great discussions on how Veristat supports and partners with its clients throughout the clinical development process by providing high-quality, innovative, and science-focused clinical development services in Clinical Monitoring, Data Management, CDISC Implementation, Biostatistics and Programming, Medical Writing, Regulatory Submissions, and Strategic Consulting.

We would also like to thank everyone who stopped by our booth last week.  It was great to see familiar faces, finally meet familiar voices, and to make new contacts.  And we hope no one walked away hungry, as we tried our best to make sure everyone left with a granola bar and a healthy dose of how Veristat can support all of your clinical development needs.

Please stay tuned! We will be announcing the winner of our drawing for an iPad2 in the upcoming weeks.

If you would like more information on how Veristat can assist all of your clinical development needs and what makes us different, please contact Bryan Adams at info@veristat.com.

This week, Veristat, a full service Contract Research Organization, continues the discussion on the six steps required for a successful CDISC Implementation for clinical trial data.  As a recap, the six key steps are:   Gap Analysis, Annotated CRF, Trial Design, Data Migration, Define.xml and WebSDM.  The last three blog entries discussed the Gap Analysis, the Annotated CRF and Trial Design datasets.  This months’ blog entry will focus on the fourth step in the process, Data Migration.

Data Migration is the conversion of source clinical study data to the CDISC SDTM dataset structure.   Veristat’s Data Migration process utilizes the CDISC SDTM Implementation Guideline, CDISC/NCI controlled terminology, and/or sponsor controlled terminology in the creation of standard and custom domains.

Veristat has gained efficiencies in the migration process by developing  a metadata-driven approach which automates components within the conversion process.  The advantages gained include consistent results, improved Quality Control and robust procedures to handle many types of data structures.

Veristat is a mid-sized Contract Research Organization and CDISC Registered Solutions Provider located just outside of Boston that has been providing services in support of clinical trials since 1994.

For more information on Veristat’s CDISC Implementation service offering contact Cindy Henderson at info@veristat.com.

If you are attending the 47th Annual DIA Conference, in Chicago, IL, June 20-22, 2011, please visit us in the exhibit hall at Booth #223 to talk to a Veristat representative about our CDISC services.

Veristat is excited to be attending and exhibiting at the 47th Annual DIA in Chicago, IL from June 19 – 23, 2011 at McCormick Place.  As a full service Contract Research Organization (CRO) Veristat is looking forward to the opportunity to meet our partners, vendors, and current and future clients at this year’s event.  Veristat welcomes the opportunity to discuss how we, as a Contract Research Organization with a focus on scientific integrity and one that takes a partnership approach with our clients, can support your clinical trial needs.

One thing you won’t want to miss from the Veristat booth is your chance to win Apple’s newly released iPAD2.   Veristat can be found at Booth #223 this year, and in addition to our raffle, we will be serving up the remedy to your hunger cravings.  So please remember to stop by our booth, register to win the iPAD2, have a quick snack, and see how we can assist you with Strategic Consulting, Clinical Monitoring, CDISC Implementation, Data Management, Biostatistics, Statistical Programming, Medical Writing, and FDA Representation services.  As always, if you want information on our clinical trial services before visiting Veristat in person, please contact us at info@veristat.com.

http://www.diahome.org/diahome/FlagshipMeetings/home.aspx?meetingid=23753&utm_source=DIAHomePageGlobal&utm_medium=Banner&utm_campaign=11001

Since 1994 Veristat, a contract research organization located in Holliston, MA, has been providing full clinical trial services to our clients on groundbreaking studies in multiple therapeutic areas.  Recently Veristat partnered on a series of studies for a Yellow Fever Vaccine.  Veristat’s contributions on the studies were recognized in a recent article of the New England Journal of Medicine.  See the full article here:   http://www.nejm.org/doi/full/10.1056/NEJMoa1009303?query=TOC
Veristat supported these trials from the early design stages through protocol development, data management in an electronic data capture system and to the completion of the statistical analysis and clinical study report writing.
For more information on how Veristat can help support your clinical trial needs please contact Cindy Henderson at info@veristat.com

This week, Veristat, a full service Contract Research Organization, continues the discussion on the six steps required for a successful CDISC Implementation for clinical trial data.  In February, Veristat initiated this series discussing the importance of Gap Analysis and followed in March with the Annotated CRF.  As a recap Veristat follows six key steps towards a successful CDISC Implementation program: Gap Analysis, Annotated CRF, Trial Design, Data Migration, Define.xml, and WebSDM. This blog will be discussing the third step in the process, Trial Design.

Trial Design Domains are datasets that clearly show the design of a clinical trial, the planned sequence of events, and the overall treatment plan for the trial. These datasets are created before CRF annotation and migration activities begin.  Given Veristat’s statisticians are often involved in both the study design planning and analytical aspects of a study, they also lead the effort in creating the trial design domains.    Development of these domains involves review of the key documents identified during the GAP analysis such as the protocol and CRFs.  Focusing on trial design has the goal of creating standardized labels for treatment arms and visits across studies.  The trial design domains are important as they are used to guide the remainder of the SDTM implementation activities, specifically the CRF annotation and dataset migration.

For more information on Veristat’s CDISC Implementation service offering contact Cindy Henderson at info@veristat.com.  Veristat is a mid-sized Contract Research Organization that has been completing clinical trials since 1994, located just outside of Boston.

Veristat, a full service Contract Research Organization, heads into spring on a positive note by continuing our series on the seven steps required for a successful CDISC Implementation for clinical trial data.  This is the second installment on the implementation of effective CDISC migration practices.  As a recap, Veristat follows six key steps towards a successful CDISC Implementation program:  Gap Analysis, Annotated CRF, Trial Design, Data Migration, Define.xml, and WebSDM.  This blog will discuss the second step in the process, Annotated CRFs.  In February 2011 we discussed Gap Analysis and this month we discuss Annotated CRFs.

For the most part those in the industry are familiar, and have worked with, annotated CRFs.  Annotated CRFs are a requirement for an FDA submission on SDTM data.  In addition, the annotated CRFs become a key document used in data migration as it provides a clear specification of the SDTM variables.  Throughout the steps of CDISC Implementation much emphasis is placed on the annotated CRF as it is used as the primary specification in generating variable mapping reports.  Sometimes annotating the CRF will help identify potential migration issues.

To create greater efficiencies, we prefer to have all issues identified during the Gap Analysis addressed before annotation of the CRFs is not started.   From the work we have completed towards submissions we have found the Metadata Submission Guideline, especially Chapter 4, an invaluable source in developing annotation standards, and implement those in conjunction with our standard operating procedures.  In addition, it is Veristat’s experience that having a solid understanding of the SDTM and database structure concept is a key requirement for those generating the annotated CRF.

The final annotation should encompass a complete set of CRFs, which accurately reflect how the data was collected throughout the course of the trial.  It can include multiple versions of a CRF if changes were made during the trial and may also include redacted CRFs if blank CRFs could not be located during the Gap Analysis.

For more information on Veristat’s CDISC Implementation service offering contact Cindy Henderson at info@veristat.com.  Veristat is a mid-sized Contract Research Organization that has been completing clinical trials since 1994, located just outside of Boston.

Veristat, a full-service Contract Research Organization headquartered outside of Boston, Massachusetts, is an industry leader for its top notch services in CDISC Implementation.  Veristat became an active member of CDISC in 2007, and earned Registered Solution Provider (RSP) status in 2009.  Veristat is one of only 15 companies currently recognized by CDISC as an RSP. In addition Veristat has entered into a partnership with Phase Forward’s Lincoln Safety Group to license the WebSDM tool to assist with validating our SDTM conversions.  The WebSDM application was developed under a Cooperative Research and Development Agreement between the FDA and Phase Forward’s Lincoln Safety Group and has been in use at the FDA since 2004.

In regards to CDISC Implementation there are key components that need to be considered to ensure that the resulting data is SDTM compliant.  These components include: Gap analysis, Study/Trial Design, Annotated CRF, Data Migration, Define.xml, and Validation.  This article will focus on the importance of the first component, Gap analysis.

Gap analysis, as defined by Veristat, is the process of capturing and reviewing key documents and files to support migration efforts.  The required documents and files include all versions of the following as available: blank CRFs, SAS datasets, format catalogs, protocols, protocol amendments, statistical analysis plans and clinical study reports.  In addition to verifying all appropriate files needed for migration have been received, Veristat cross-checks these documents for their consistency.  For example, do the CRFs accurately represent the data collected (or vice-versa) and similarly do the protocol amendments match the CRF versions used? Veristat will track all discrepancies and work with our clients to resolve any identified inconsistencies.

The key advantages to performing a Gap Analysis include being proactive verses reactive, defining the scope of effort and identifying the impact of data collection on migration activities. Being proactive is the key benefit of performing the Gap Analysis early in the process, especially with legacy data migrations where the structure of these files and the availability of the required data are often uncertain. Often, a thorough review of the CRFs and the source data will be a good indication of the effort needed in the migration.  For example, in some cases, CRFs may look similar across two studies, but different standards used in the database (because of vendor changes) may make one study much easier to migrate. The basic intent of a Gap Analysis is to identify potential issues early on in the process that will impact migration efforts later.

For more information about Veristat’s CDISC implementation services, and what Veristat can do to compliment your clinical trial needs, please contact Cindy Henderson at cindy.henderson@veristat.com.  Please visit Veristat’s website at www.veristat.com for more information about the company.

Clinical research is a growing profession with a wide variety of positions to choose from along with room to grow and advance. New medications, devices and diagnostics constantly need to be developed and tested to ensure they get to the market as soon as possible. This is why clinical research is one of the largest areas of the pharmaceutical and biotechnology industry.

Clinical research is a team effort. A standard team can be made up of the following people: physicians, nurses, pharmacists, technicians, clinical research associates, data managers, regulatory specialists, statisticians, programmers, medical writers, and project managers. Not only will you have the chance to work with a variety of different people, your surroundings will not be limited either. Many clinical researchers are found in places such as hospitals, research facilities, pharmaceutical companies and contract research organizations (CROs).

If you are looking for a job where you can be in a cutting edge field with the intellectual challenge and chance to work with some of Boston’s most talented individuals, then clinical research might be the profession for you. At Veristat, a contract research organization, we are constantly creating and filling new and existing positions with dedicated individuals looking to either just start their careers in clinical research, or those who are looking for a place to grow within the industry. Please check Veristat’s career opportunities for the most up to date positions available.