On September 14^th in Washington D.C., Cindy Henderson, the Senior Director of Strategic Development at Veristat, a full service contract research organization, will be chairing the annual 2010 SOPs DC Conference, “Effective R&D SOPs, Process Maps and the Quality System”.   This is a one day conference focusing on the importance and effective implementation and management of SOPs.  Speakers include industry leaders from Pfizer, Novartis, and other global CROs.  This conference has been hailed as a must for continuing professional development in the industry.  Topics to be discussed include SOP audits, SOPs during mergers, strategies for effective SOP training, and new industry regulations on SOPs.

In addition, if you mention Cindy Henderson you will receive an additional 10% off of the registration price for the conference.  Please see the link above for more about registration. Veristat looks forward to meeting you there.

For more information on Veristat, a full service contract research organization, and to speak with Cindy Henderson, please email your inquiry to info@veristat.com

Over the past decade the creation of the virtual pharma or biotech has been on the rise.  The amount of time it takes to get a drug on the market is estimated to take an average of 10 years.  With this in mind the emergence of the “virtual” pharma or biotech company has emerged.  Virtual companies are generally run by a few core people with all other services outsourced.  This allows the company to pick and choose, in an a la carte style, how and who they will go to for services.

Here comes to play Veristat.  As a full service Contract Research Organization, with over 15 years of experience, Veristat too has grown over the years to become a choice of some “virtual companies”. Veristat generally starts off with these companies offering strategic statistical and medical writing consulting.  As the company grows, so do the service offerings Veristat helps manage for it.

Veristat invites your company to look into our services, virtual or not, and how we can provide you with the top notch service in your clinical trial.  Please contact Cindy Henderson at info@veristat.com

As a full service CRO, Veristat knows the clinical trial process is full of many twists and turns and navigating through unforeseen challenges can be hard for many Sponsor companies and even harder for physicians and patients to know what is out there.

Choosing Veristat as your Contract Research Organization can help ease this process as we can guide you through the many steps to take.  Veristat prides itself on a partnership approach with clients, becoming an extension of your organization.  In addition, part of our mission statement is to keep up with the latest technologies available, including assisting sites and physicians, used in the clinical trials we help manage, to stay aware of new advancements that help us all with the ultimate goals of curing disease and improving the quality of life for all.

Recently announced at the annual ASCO meeting the FDA and ASCO have partnered to help provide medical education for physicians and patients looking for information on new clinical trials that are being conducted. In addition to easier navigation through the system , it also outlines the requirements that are needed along the way.  This shows how the industry is working together to simplify access and help aid in recruitment for trials.  As a full service CRO offering monitoring and patient recruitment services, Veristat is happy to help educate our sites and sponsors on the details of this new advancement, and help navigate through the process of clinical trials.

For more information on how Veristat can help you ease through the drug development process contact Cindy Henderson at info@veristat.com

How exactly can a CRO assist you?  A Contract Research Organization can assist you achieve savings by providing the outlet to outsource your clinical trial needs through the drug development process.  This is a positive choice when you have a company like Veristat to work with.

How can Veristat assist you?  Well the answer is simple.  Veristat provides a partnership approach which allows us to become an extension of your team, saving you money, creating efficiencies, and working with you every step of the way through the clinical trial process.  As a full service CRO Veristat helps you navigate through Clinical Monitoring, Data Management, Biostats, Medical Writing, Regulatory Submission, and CDISC Implementation in an easy and fluid manner.

Please contact Cindy Henderson at info@veristat.com for more information on how Veristat is your number one outsourcing choice for clinical trials.

As a full service Contract Research Organization, it is important to ensure constant exposure in the industry for Veristat.  This is why Veristat is proud to announce its advertisement in the August issue of the DIA Global Forum. With a successful DIA meeting behind us we begin to look forward to the rest of 2010 to see how we can assist companies in efficiently conducting clinical trials.

Veristat is happy to be an active participant in DIA and is looking forward to the new advertising opportunity.  Please look for our ad next month.

Veristat would love the opportunity to hear from you.  Please contact Cindy Henderson at info@veristat.com

Veristat knows that in order to succeed as a full service contract research organization it is vital to distinguish itself in this industry.  Many sources have looked to contract research organizations to continue growing and according to the article, Playing Big Pharma with CRO’s, this trend will continue.  As a mid-sized, full service CRO Veristat is able to closely monitor costs and maximize efficiencies for pharmaceutical, biotech and medical device companies.  As this article shows, outsourcing to a CRO will provide greater efficiencies to a company’s bottom line and to their drug development programs.

Our size, in comparison to larger competitors, allows Veristat to be an extension of your organization and a partner to your team. This is especially beneficial in allowing your company to specialize in the areas of drug development expertise while Veristat assists you in running your clinical programs.   All the while we create maximum efficiencies, provide you with excellence from our teams, and monitor costs to help keep your clinical study in budget.

Our clinical trial partnerships begin with strategic consulting and medical writing of your protocols and continue on to encompass clinical monitoring, data management, biostatistical analysis, programming, FDA representation, and CDISC Implementation.

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

Thank You from Your CRO

As another year has halfway come and gone Veristat, your full service Contract Research Organization, would like to say thank you to all of our clients and vendors.  It has been another wonderful year and we are happy to provide our customized service and partnership approach to each project we work on with you.

Veristat works with our clients to provide the best of our service offerings in areas of clinical monitoring, data management, biostatistics, medical writing, CDISC, strategic consulting, FDA representation, safety, and for DSMB support.  We pride ourselves on becoming an extension of your company and having the flexibility to do so.

Should you wish to know more about our service offerings please contact Cindy Henderson at cindy.henderson@veristat.com

Veristat at DIA

The 46^th Annual DIA went off without a hitch as Veristat, a full service Contract Research Organization, exhibited at Booth 930.  With the Washington Convention Center full and buzzing it was a great opportunity to meet and talk with our current clients and those who we look forward to working with on their clinical trials in the future. As a full service Contract Research Organization we are able to offer a great variety and of course a great team to Sponsor’s.

This week Veristat did the drawing for the apple iPAD.  We are pleased to congratulate the winner: Shawna Ruffin with CSL Behring.  Shawna thank you for stopping by our booth and helping make this a great DIA for Veristat.

For more information on how Veristat can assist you with your clinical trial needs please contact Cindy Henderson at info@veristat.com

As a full service Contract Research Organization, Veristat’s commitment to integrity and high quality create many opportunities for company growth and repeat business.  One key element in our quality management approach is our Corrective Action/Preventive Action (CAPA) Reporting system, which was implemented in August 2009.  With an emphasis on compliance, CAPAs are required for all deviations, whether intentional (e.g., a deviation from standard procedures directed by a client) or unintentional, as a result of human error.  We also capture client satisfaction data as well as recommendations for process improvements.  For example, some process improvements are modifications to current systems or SOPs, or implementation of new processes, or enhanced training.  CAPA reports may be submitted by any employee, and the system’s tracker and all CAPA reports are transparent and visible to all employees 24/7.  As illustrated in this white page, CAPA is especially important in the healthcare industry.  As a top-notch, competitive CRO, Veristat is keeping up with industry standards. http://www.metricstream.com/whitepapers/html/corrective_preventive_actions.htm

In our first year, we have learned that communication and resolution are the most important elements of the system.  The reporting process has been augmented to ensure that all involved team members, all relevant line managers, and key senior managers are notified about the CAPA prior to its formal submission.  In our experience, this notification step helps to build consensus and clarity regarding the root cause at issue.  This helps pave the way for agreement on the action items recommended for resolution.  Resolution is pivotal to successful implementation of process improvements.

The stated goal of Veristat’s CAPA system is to improve Veristat, a full service CRO, as a company.  We always are striving to better ourselves and our CAPA system is proof of that commitment.  For more information on how Veristat can assist your clinical trial needs please contact Nicole Powell at info@veristat.com

Veristat, a full service Contract Research Organization, strives to provide the best possible training and work environment for our employees.  To better realize this goal, Veristat has recently launched Veristat University (VU). This training program, coordinated by the Corporate Compliance group, is based on a structured, role-based curriculum. Training priorities are driven by senior management goals, with cross-functional training at the top of the list. All employees are required to take trainings on Veristat’s service offerings as a full service Contract Research Organization.  This includes introductory courses on Clinical Monitoring, Data Management, Biostatistics, CDISC Implementation and Medical Writing.   Course offerings are engineered to provide each employee a broad clinical research-based education to become better Contract Research Organization employees and this is complemented by detailed, task-specific training, directly related to day-to-day responsibilities of project team members.

The CRO generated curriculum allows for a flexible approach – training can be offered to many employees in a traditional classroom style or as one-on-one  mentoring.  Courses are offered in three levels: Introductory courses are ‘100 level’ and are intended for all employees, advanced courses are ‘200 level’, and for the most complex training, a ‘300 level’ exists.  All employees are required to take all 100 level courses to foster company-wide, cross-functional training. In addition, the VU curriculum incorporates all required training for Standard Operation Procedures (SOPs) and regulations.

Our first semester is underway. Check back soon for other VU announcements! For additional inquiries into Veristat and how our employees can better assist your clinical trial needs, please contact Nicole Powell at info@veristat.com