Since 2006 Veristat, a full service Contract Research Organization, has been helping to support the United Way during the December holiday season.  This will be our fourth year supporting the Gift of Giving Program, sponsored by the United Way, helping families in our local area outside of Boston.  With another year of our economy trying to recover and many families still in need, Veristat staff enjoy taking the time to share with our community and participate in this work.

This year Veristat is assisting the children of over 30 families.  By providing presents of clothing, shoes, and small toys to families in need, Veristat hopes to encourage the spirit of giving during this holiday season.
For information on how you can Live United this holiday season contact your local United Way.  For more information on Veristat please email Cindy Henderson at info@veristat.com

Located right outside of Boston, Veristat is a full service Contract Research Organization (CRO). Founded in 1994 by John and Barbara Balser, Veristat has grown in the industry and is known for its work in numerous therapeutic areas.  Included in Veristat’s therapeutic expertise is our work in hematology.

For the first time this year, Veristat will be in attendance at the 52nd annual conference for the American Society of Hematology (ASH),  December 4th -7th in Orlando, Florida.  John and Barbara Balser are excited for this opportunity to attend and represent Veristat and the work that has been accomplished since its inception.  Should your company be in attendance at the 52nd annual ASH conference please be sure to say hello to John and Barbara.

For more information on Veristat as your Contract Research Organization, please contact Cindy Henderson at cindy.henderson@veristat.com

As a full service Contract Research Organization with one of our core values being a collaborative approach to clinical trial development, Veristat is happy to serve as a guest blogger for other clients and businesses.  Recently Veristat was asked to contribute as a guest blogger with goBalto.  Starting with our first part in a series on CDISC Implementation, Veristat has identified the importance of Gap Analysis, one of the key components towards CDISC Implementation.  Please visit the link below to read more.

http://blog.gobalto.com/2010/11/17/52-perspectives-veristats-look-into-gap-analysis-for-cdisc-implementation/

For more info on goBalto please visit their website at www.gobalto.com/about . Please contact Cindy Henderson, Sr. Director of Strategic Development at Veristat, for more information on Veristat’s services, including CDISC implementation, and how we can assist you, info@veristat.com

As a full service Contract Research Organization located just outside of Boston, Veristat prides itself on providing our clients with a skilled and experienced Project Management team.  Continuing our series on Veristat’s services, we conclude with a focus on the leadership at the center of all Veristat services.

For the successful delivery of any clinical program, it is essential to have an experienced project team led by a strong Project Manager who will be ultimately responsible for the administration of the clinical monitoring, data management, analysis and reporting activities for our clients.  The Project Management team at Veristat is comprised of individuals with a robust background both in clinical and technical knowledge that can help facilitate the development of a seamless working relationship between Veristat and our clients during the course of a clinical program.

The Project Manager is at the center of all project activities and works with the entire team to ensure all project deliverables are of the highest quality and are completed on time and within budget.  Significant emphasis is placed on flexible and creative problem solving approaches that highlight efficiency and streamlining of activities, thereby providing optimal solutions to client needs. The Project Manager works closely with the internal and client team members to provide clear communication channels and define roles and responsibilities, to monitor ongoing progress, maintain high team morale, and keep team contacts aware of project status and any issues in need of resolution.

For more information on Veristat’s services, please contact Cindy Henderson at info@veristat.com

Veristat, your first choice for a full service Contract Research Organization, is happy to have the opportunity to once again be exhibiting at the CDISC Interchange North America 2010, being held this week in Baltimore Maryland.  As previous exhibitors and Registered Solutions Providers of CDISC, Veristat realizes how important it is to support CDISC initiatives and continue to tell prospective clients about Veristat’s achievements in CDISC Implementation.

As a bonus this year Veristat will be raffling off an Amazon Kindle to one lucky attendee at this year’s conference! To be eligible please stop by our table and speak with the Veristat representatives from our Data Standards team.  Our Data Standards team will be happy to answer any questions you have about your current CDISC Implementation needs and  how Veristat can assist you with any of your other clinical needs.

For more information on Veristat please email info@veristat.com for our Business Development Department.

Continuing our series on the core services offered by Veristat, a full service Contract Research Organization, we turn our attention to Data Management.  Data Management is a world comprised of many technical applications and tasks and the employees in Veristat’s Data Management department pride themselves on their attention to detail and experience in the industry.

Veristat’s Data Management group has the ability to build and design a trial in both paper and EDC formats.  For paper studies Veristat currently uses ClinTrial.  Veristat is a full enterprise adoption provider of the Phase Forward InForm system.  Veristat also has experience utilizing other EDC systems including Medidata RAVE and various sponsor proprietary systems.
As a department within a full service CRO, the Data Management group will lead the study through database design and build, creation of CRF pages and the Data Management Plan and Data Validation Specifications, generation and completion of all queries and edit checks, coding of all AEs and Conmeds, SAE reconciliation, and through to the final database quality control and lock.
The Data Management team works closely with all departments during the course of the trial, most notably during the CRF/eCRF design and database build process.  All CRFs/eCRFs are reviewed by lead biostatisticians and medical writers to ensure all critical data points will be captured to assist with the full analysis of the trial at all stages and to ensure compliance to CDASH standards.
For more information on how Veristat’s data management department can assist your clinical trial please contact Cindy Henderson at info@veristat

Veristat, a full service Contract Research Organization, is happy to announce our upcoming attendance at the CDISC Interchange 2010 on November 3rd and 4th in Baltimore, MD at the Renaissance Harborplace Hotel.  This will be Veristat’s second year in a row to host a booth and exhibit at the conference.
Veristat’s CDISC Implementation services are top notch in the field. As a result of this, and combined with our vast experience and status as a Registered Solutions Provider for CDISC services, we are excited to continue to get the word out in speaking with people at the conference.  Veristat looks forward to assisting you with your CDISC Implementation needs so please stop by our table and speak in more depth with our Data Standards team.
For more information on CDISC services Veristat is able to provide you with in support of your clinical programs , please email Cindy Henderson at info@veristat.com

As we continue to explore the service offerings of Veristat, a full service Contract Research Organization, we turn our attention to our medical writing capabilities and how, as a Contract Research Organization, Veristat’s medical writers are among the best in the industry.

Medical writing was the second of the two core service offerings upon which Veristat was founded. The medical writers at Veristat are top notch and bring many years of industry experience to the table. Not only do Veristat Medical writers have many years in the industry but their experience also spans a wide range of specialized therapeutic areas.

Veristat’s medical writing team has extensive experience in protocol concept design, protocol and clinical study report writing, Investigator’s Brochures (IBs), manuscripts and annual reports.  In support of submissions, our medical writers also create integrated summary documents including the Integrated Summary of Safety, Integrated Summary of Efficacy, Clinical Summary of Safety and Clinical Summary of Efficacy reports.

For more information on how Veristat’s medical writing department can assist your clinical trial please contact Cindy Henderson at info@veristat.com

As a Contract Research Organization, it is important for Veristat to constantly grow and change as the industry grows and changes.  This is why Veristat began offering clinical monitoring as a core service; to expand its already solid service foundation in clinical trials and provide the most to our clients.  Three years ago Veristat established a clinical monitoring department rather than continuing with the established partnerships we had used in the decade prior.   In this time we have assisted in running several Phase III trials and look forward to the growth that lies ahead.

Veristat’s clinical monitoring department manages the complete monitoring process with each client from initial site selection, site qualification and feasibility surveys through all site initiation visits and into the final close-out of each site.  Veristat works closely with the site staff and investigator to ensure total compliance with United States Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, the approved clinical study protocol and clinical monitoring plan, and applicable Standard Operating Procedures (SOPs).

Veristat’s clinical monitoring personnel promote the development and maintenance of positive, professional working relationships with investigative site personnel. Focused telephone contact between scheduled on-site visits fosters these relationships and ensures optimal use of study personnel time during scheduled on-site visits.  Internally, clinical monitoring, data management, and biostatistical personnel work in a coordinated fashion to ensure maximum efficiency of on-site monitoring visits as well as data availability for project milestones and analyses.

For more information on Veristat and how our clinical monitoring department can assist you please email Cindy Henderson at info@veristat.com

As a Contract Research Organization, it is important for Veristat to constantly grow and change as the industry grows and changes.  This is why Veristat began offering clinical monitoring as a core service; to expand its already solid service foundation in clinical trials and provide the most to our clients.  Three years ago Veristat established a clinical monitoring department rather than continuing with the established partnerships we had used in the decade prior.   In this time we have assisted in running several Phase III trials and look forward to the growth that lies ahead.

Veristat’s clinical monitoring department manages the complete monitoring process with each client from initial site selection, site qualification and feasibility surveys through all site initiation visits and into the final close-out of each site.  Veristat works closely with the site staff and investigator to ensure total compliance with United States Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, the approved clinical study protocol and clinical monitoring plan, and applicable Standard Operating Procedures (SOPs).

Veristat’s clinical monitoring personnel promote the development and maintenance of positive, professional working relationships with investigative site personnel. Focused telephone contact between scheduled on-site visits fosters these relationships and ensures optimal use of study personnel time during scheduled on-site visits.  Internally, clinical monitoring, data management, and biostatistical personnel work in a coordinated fashion to ensure maximum efficiency of on-site monitoring visits as well as data availability for project milestones and analyses.

For more information on Veristat and how our clinical monitoring department can assist you please email Cindy Henderson at info@veristat.com

Since 1994 Veristat, a contract research organization, has been providing many full clinical trial services to our clients.  To highlight one of our many core offerings, Veristat began as a company providing excellence in biostatistical analysis.  Led by the company’s president, Dr. John Balser, Veristat’s statisticians are an integral part of the trial process from the very beginning- providing input on protocol concept, statistical sections of the protocol and CRF design.   Throughout the course of the trial Veristat’s statisticians create randomization schemes and compile sample size calculations for the project. With all of Veristat’s statistician’s based in-house, lines of communication flow more freely throughout the clinical trial process with other departments, gaining optimal efficiency.

Veristat’s statisticians are called on regularly to provide statistical consulting services and to serve as representatives at the FDA and other international regulatory agencies.  In addition Veristat statisticians have served as members of Data Safety Monitoring Boards as needed by our clients.  With the vast expertise held by the staff, clients continue to return to Veristat at the beginning of each program for statistical analysis and continue on with Veristat running the program.

For more information on how Veristat’s biostatisticians can help meet your trial needs please contact Cindy Henderson at info@veristat.com