WCC’s focus on operational metrics and clinical statistics continues to advance and improve the accuracy of medical imaging. To ensure data validity throughout the trial process, WCC follows a sophisticated statistical program that includes the creation and validation of critical listings to support FDA audits, SAP consulting, statistical methodology development for reader training and testing, and sample size estimations for reader variability testing. This means that all sponsors can be assured of a streamlined FDA review process that can be verified against WCC’s independent data.
From Start to Finish
From advanced tools that improve assessment precision to an image quality control process that streamlines reader training and testing, WCC’s measured control of reader variability and unparalleled commitment to data accuracy spans the entire duration of the study.
For each trial, WCC takes an adaptive approach to training and testing by developing a plan that includes:
We also maintain regular communication with the entire reader team by providing trial-specific newsletters that include data on individual and team performance, study assessment criteria, evaluation discussions, and specific highlights of challenging cases.
Data Management
Biostatistics
Worldcare Clinical's industry-leading biostatistics and data management services are setting the course for reducing variability and increasing validity of trial imaging data.
Definition drift. Reader turnover. Missed or incomplete training. If your CRO isn’t actively monitoring the validity of the imaging data as it is being collected, your submissions could be at risk. At WorldCare Clinical, we are leading the industry in the proactive assessment of imaging data so that sponsors can identify potential issues early, and correct them. We keep a close eye on the entire process including robust training, regular communication on trial status, intra- and inter- reader reliability testing, performance assessments, retraining, and more. Let us show you how we are using today’s most advanced biostatistics and data management methods to deliver imaging data validity and consistency.
WCC offers sponsors not only its own in-house radiology expertise, but a wealth of radiologists from the world’s most renowned medical institutions, including Massachusetts General Hospital (MGH) Department of Radiology and the University of Chicago Medical Center (UCMC). Based on its access to this expertise, WCC is able to offer sponsors unique thought leadership in working through review criteria to determine optimal imaging modalities and study design.
Unique to WCC, our rigorous therapeutic model provides our sponsors with:
Oncology: Prostate, pancreatic, breast, lymphoma, colorectal, brain, liver, melanoma, ovarian, sarcoma, and renal cell carcinoma.
Central nervous system: Alzheimer’s disease, epilepsy, multiple sclerosis, Parkinson’s disease, traumatic brain injury, stroke/hemorrhage, vascular dementia, and other neurodegenerative diseases and cerebrovascular disorders.
Musculoskeletal: Sports-related injuries, pain management, bone and muscle tumors, osteoporosis.
Women’s health: Uterine fibroid disease, device for detection of ovarian cancer.
Cardiovascular: Cardiac contrast agents, and invasive and noninvasive vascular imaging in disease states such as myocardial infarction, congestive heart failure, peripheral vascular disease, and coronary artery disease, in addition to devices such as drug-eluting stents.
Metabolic: Obesity, muscular dystrophy, diabetes, hyperthyroidism, and Addison’s disease.
For more information on these and other services please email us at info@wcclinical.com or call us at 1 (888) 816-4721.
The WorldPRO® technology enables efficient, site-specific communications with total transparency to sites, monitors and sponsors. Built on a platform that moves over 1,000 images per day from 350 sites worldwide, the WorldPRO system facilitates remote review by independent readers. Our secure network provides a seamless data flow between sites, physician readers, and the sponsor for total project control at every step of the trial, and the most advanced transmission technology in the clinical trial world guarantees process efficiency.
Because the WorldPRO system supports readers remotely, we also provide round-the-clock technical support to imaging centers in global clinical trials and work with imaging formats of all kinds. Sponsors have the freedom to work with the best assessment talent anywhere on the globe, and the confidence of knowing our process for preparing sites, managing data, and submitting images ensures consistency - no matter where in the world your readers are.
Our approach to trial control and commitment to data accuracy are the foundation for regulatory services that frame the entire study from initial design and statistical plan to project management. We conduct every trial with the goal of maximizing the potential for successful regulatory submission, and we work closely with sponsors to determine the most effective way to meet agency requirements with services that encompass all regulatory aspects of trial design, execution, and compliance.
Specific regulatory services include:
Agency Experience: Positioned for Success
WCC brings a specialized level of imaging expertise to sponsor trials, thanks to an extensive history with the FDA’s Medical Imaging Division and the EMEA. Currently participating in SPA meetings with the FDA, we also offer unique auditing experience after incorporating agency feedback to enhance audit trails for EAC review. In addition to implementing a new audit trail for all EACs participating in our trials, our staff has direct experience working with inspectors from the FDA, MHRA, and EMEA, and is a strong partner for advising sponsors on a well-informed approach to regulatory review.
Good Clinical Practice Consolidated Guidelines, Federal Register Vol. 62 (90)
EACs & Oncology Trials
Particularly for oncology trials, the use of an EAC can be of tremendous help in ensuring objectivity and comprehensiveness of assessment, and validity of efficacy results for regulatory submission. For sponsors requiring EAC reviews, WCC leverages its relationship with Massachusetts General Hospital to provide oncology, pathology and dermatology reviews. Using WorldPRO, WCC performs a digital assessment that collates radiology, pathology, photography, and clinical data in a user-friendly format, facilitating efficient review and confirmation of assessment by trained clinicians. Unique to WCC, EAC reviewers are able to make their own assessment, saving measurements on radiology, dermatology and pathology images to maintain critical audit trails.
WCC offers total planning and execution of an EAC for any imaging study with services that include:
Quality Control & Regulatory Optimization
WCC works specifically to streamline the assessment process by integrating the critical components of the data management and statistical analysis plans of the overall imaging trial into the EAC process. By allowing sponsors access to the imaging and other clinical data before it moves to final EAC review, WorldPRO minimizes the need for EAC re-reads and ensures that sponsors can most effectively utilize EAC results for regulatory submission. This transparency throughout the trial enables sponsors to confirm that all data has been properly obtained and received by investigators before final assessment, and prevents against multiple re-reads that can negatively impact chances for FDA approval. WCC’s fully digital process also removes bias in document handling, and an efficient data management system streamlines all data capture and transmission to optimize workflow and ensure total control throughout.
WorldCare Clinical works with sponsors to design and configure a workflow that meets the specific needs of each trial, while enabling a transparent view of the study at any time of the day or night, regardless of location.
Whether your trial requires a basic workflow such as a single radiologist review with a single modality or a more advanced workflow such as a double-blind read with adjudication of multiple imaging modalities, or even a global trial that must adhere to international compliance standards and regulations, WCC provides an image management technology that is configurable to the specifications of your trial. This variety in processes from trial to trial increases the importance of technical insight in the science of imaging as well as in the operational details of workflow management.
From generating queries, events, notifications, and task lists for each trial segment, WCC’s WorldPRO image management platform is easily accessible with a single sign-on for Independent Review Committees and EAC members, providing access to:
Additionally, reviewers have the flexibility to review cases wherever and whenever it is most convenient for them, allowing for subjects to be assessed in rapid turn-around times and eliminating the need for coordinating EAC sessions.
"EACs are becoming more prevalent, especially in oncology trials, where regulatory agencies are looking for a more integrated assessment of patient outcomes. The latest version of our WorldPRO® platform was designed to accommodate complex workflows and integrate the review of radiology, pathology, photography, and clinical data to ensure that sponsors benefit from a more efficient and holistic assessment of disease, which reduces study timelines and goes a long way in improving data accuracy."
"3D MRI imaging analysis has become instrumental in helping us expand our service offerings to support more oncology and CNS studies. Working in collaboration with our clinical operations team, we provide expert quality assessments of imaging studies and assist project managers and sponsors in modifying imaging criteria based on disease indication and location."
© 2012 WorldCare Clinical
