1. Jane Tervooren, Director&Co-Founder:  Validated Claim Support is an expert laboratory in imaging and photography, could you tell us more about the benefits that these techniques bring to cosmetic brands?

We offer the highest quality, cutting-edge, high-resolution photography to help document product efficacy over a given treatment timeline or product usage cycle.

VCS is proud to provide the most highly regarded and reproducible panelist image capture available on the market today.  If a product works, we’ll help prove it and we’ll give your customers a visible reason to believe in your brand.

Our techniques have been refined over many years providing the highest level of service and quality to sponsors around the world.  It comes down to control of environmental variables, panelist expression and comfort while being photographed, and then 18 years of clinical expertise in coaching and directing.

Photos are taken from multiple angles inside one of our temperature and humidity-controlled studios adjacent to our Acclimation and Claims/Efficacy Suites. Variables such as lighting, positioning, ambient environmental factors, panelist location and facial expressions and angles are monitored and controlled throughout the study.  The resulting data output is an extremely detailed and accurate since all of the variables except for time and the product efficacy have been mitigated or eliminated entirely.

Final photographs are carefully cropped and can include objective pixel quantification data that allows us to accurately measure treatment parameters such as skin tone, shadow, fine lines and wrinkles, contrast, L*, A*, B* and RGB values.

We offer imaging using either Canfield VISIA CR capture technology or our proprietary Validated Clinical Photography which both have their own unique pros and cons.

Both of these methods can be utilized to include photographic analysis which will demonstrate improvement from baseline. We have 3 completely customized studios onsite, and we can shoot a variety of unique underlying lighting conditions including fully polarized, standard, high intensity, UV, cross-polarized, and a variety of closeup/macro options.

Validated Photography provides the ability to capture clinical images not just on the face but also on a multitude of other treatment areas on the body.

Our photographic techniques can be applied on as few as a handful of subjects.  If a product genuinely works, we can help build a custom-tailored marketing package to help its core competencies really shine through.

The efficacy of a product can be brought to the forefront of promotional materials and we can work to develop a completely custom tailored individual package that brings marketing and clinical science together.

Imitation is flattering, but companies shouldn’t trust their products with anything less than the best clinical photography in the industry.

2. Brian Ecclefield, Managing Director: How is Validated Claim Support responding to the demand for increasingly ethical clinical studies?

Validated was founded to provide our clients with the most accessible & auditable data and clinical study records at every stage of the process.

Data centers are 100% cloud based and we use Egnyte for Lifesciences specifically because it’s both HIPAA and GDP focused, allowing us to store panelist records, proprietary information, and study data based on sponsor and unique international regulatory requirements.  We can set data termination and archiving rules specific to each project.

Our process is streamlined in a way that CRO’s with labs and IT storage located across international borders generally can’t match.  Panelist image rights are clearly defined in perpetuity and not based on whatever the latest privacy policy may be.

We have strict conduct standards and remove subjects from our database if they are non-compliant. Our volunteers aren’t just a number and because they are not participating in high volume, low margin testing, they enjoy trying the latest skincare products and are paid well to be compliant.  All subjects are technician graded to have specific underlying conditions and qualify based on expert grading, not self-perceived qualification.

In order to produce exceptional clinical photography there are 3 absolutes: a product that works, a panel with a visible, treatable condition, and extremely well managed laboratory controls. If any of these elements are lacking, the study and marketing images are likely to be substandard.

VCS was among the first to switch to digital, debit card backed IRS traceable 1099 payments using Clincard and RealTime SitePay, eliminating cash from the payment process. One would think that ethical tracking of panelist payments would be the norm, but we are consistently surprised to hear that many labs still pay cash or write physical checks to their participants.

Our mission is to provide clients with the highest quality, unbiased ethical claim support in the industry with no exceptions.

3. Stephanie Van Hollemeersch, Quality Manager: How does Validated Claim Support integrate quality requirements into the different stages of clinical studies?

Validated Claim Support conducts clinical studies in accordance with Good Clinical Practice (GCP) and therefore has 2 main focuses: panelist protection and data integrity.

Quality begins with the study design, by ensuring that the protocol properly describes the Sponsor’s needsand that the Informed Consent is easily understandable to panelists while protecting their rights, integrity and confidentiality.

After the study begins, the Quality Department monitors to ensure that it is conducted following the study protocol. We also review data output including questionnaires, instrumentation, and expert grading records.

At the study end, the Quality Department ensures that all data reported to the Sponsor is credible and accurate.

In addition to study-specific monitoring, Quality Team members also oversee Validated’s processes and documentation, and we work with department managers to define staff’s roles and responsibilities. We also ensure that all staff members are trained according to their Training Plan allocated during the hiring process and which is reviewed annually.

All reputable labs should have processes that are regularly audited (externally and internally) and monitored through Key Process Indicators. VCS is an FDA registered and inspected facility, and we pride ourselves on ensuring perpetual continuous improvement.

New technologies drive fresh challenges for VCS, as we integrate the latest data capture and analysis systems, equipment software and subject data protection global compliancy. The next step which is in process is the implementation of ISO 9001:2015.

We look forward to continuing to provide services that meet or exceed customer and applicable statutory and regulatory requirements and prioritize panelists’ and sponsors’ safety and confidential information protection above all else.

4. Jane Tervooren, Director&Co-Founder: Validated Claim Support is a private and independent laboratory. How does this specificity allow you to stand out from other clinical testing laboratories?

VCS was designed around providing an alternative to the CRO status quo. We are privately held and pride ourselves on our single site clinical model.  This allows us to have unparalleled controls over variables like temperature and humidity-control, staff training and expertise, and reproducibility of things like applied pressure with probes and instrumentation.  Our site was custom built to make our participants feel comfortable in a controlled, clinical setting – we’re often told it feels more like a spa than a laboratory, and that’s exactly what we were hoping to achieve.

Project management is handled by our cofounders with no exceptions – this allows us to provide unparalleled customer service on each clinical study design. We spend as much time as necessary communicating the intricacies of each study with our clients both large and small.  We can make decisions quickly and customize studies in a way that no major lab conglomerate possibly can. Protocols and methodologies have all been developed to streamline domestic and international product launches while considering the needs of the individual niche market manufacturer.

We can also integrate external protocol at a client’s discretion. Our goal is to make the experience as enjoyable as possible and to go above and beyond expectations.

Companies shouldn’t settle for the “CRO” status quo – unyielding customer service can be the difference between a highly successful product launch and a mediocre marketing delivery. Clients deserve to experience the best customer service in the industry.

*publirédactionnel

CONTACT

Jane Tervooren

jane@validatedcs.com

+(201) 331-9300

www.https://validatedcs.com/