Profect® Clinical Imaging Services provides clients with customized photographic and software services for clinical research studies in the pharmaceutical, cosmeceutical and aesthetic medical device industries.

oUR SERVICES:
Today’s clinical research studies demand precise, reproducible, high quality imaging. With the advent of non-invasive surgical procedures, advanced technology in lasers, development of new skin care product lines and new dermatologic and plastic surgery procedures and treatments, high quality photographic documentation is needed now more than ever in the competitive world of medicine, aesthetics and health care.

Profect® Clinical Imaging Services Group (CIS) provides all of the necessary elements to ensure accurate and reliable image documentation.

PHOTOGRAPHIC CONSULTING & PROTOCOL DEVELOPMENT:
Our consulting services can help you determine the right photographic equipment and protocols needed for your clinical study site(s). CIS can provide any of the following:

  • Recommendations for hardware and software configurations to best suit your application.
  • The newest photographic capturing and imaging techniques for obtaining data and/or photographic images for your study.
  • Customized software applications developed by Profect’s own software development team and/or by industry partners to extrapolate data suited to your study.
  • Development of protocols to ensure reliable, consistent and accurate capturing of your study images.

Whether you need to document changes of the skin’s surface
and/or subsurface for the efficacy of new products or obtain
measurements from patient images for surgical devices, we
have the right solutions for you.

STAFF TRAINING & SUPPORT:
Quality medical photography is often left to untrained staff members to perform. CIS offers on-site installation, experienced training and service and/or web-based training so that staff members and site technicians are fully competent to operate the equipment.

CIS can also staff your clinical study with experienced, professionally-trained medical photographers. Profect’s medical photographers are trained in proper standardization and imaging protocols to ensure that your study images will be of the highest quality. Our photographers can accommodate both short- and long-term studies.

HIPAA-COMPLIANT, SECURE, ONLINE IMAGE HOSTING:
Our HIPAA-compliant remote server storage service offers the convenience of monitoring your photographic images from any location that has Internet access. In addition, you can restrict permissions to varying degrees for your CRO, sponsor and on-site staff.  Plus, you havethe assurance that your images are backed up on a remote site should you need to recover images from a study site.

We provide secure methodology for FTP file transfer, storage and access to your studies’ photographic images and operate in compliance with ICH GCP and US FDA Rule 21 CFR part 11.

IMAGE MONITORING & QUALITY CONTROL CHECKS:
CIS monitors your clinical images in near real-time providing you with feedback throughout the course of the study. In this way, technical issues or suggestions for image improvement can be noted when they arise, rather than at the end of the study, to optimize the photographic data you capture and ensure consistent photographic results.

GRAPHIC PRODUCTION OF POST-STUDY MATERIAL:
Complete graphic support is available to you through CIS to help you customize your image data for publication, presentations and marketing purposes. High quality print portfolios can be built according to your study(ies) need. CIS tailors its graphics support to your exact requirements
.

QUALIFIED PANEL REVIEW & ANALYSIS:
By enlisting the support of physicians, research associates and individuals with appropriate expertise and experience, CIS forms qualified panels for review and analysis of your clinical images. CIS can coordinate the review process and establish the evaluation criteria and techniques to provide you with valuable data. This information can be used to substantiate
your study and help you determine which images best support your research findings.

For more information or to request a proposal, email: cis@profectmedical.com.

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