This experience has helped us hone our operations and optimize our resources to deliver a team with the right combination of medical expertise and passion for imaging science. Our people are the heart of WorldCare Clinical and their dedication to medical imaging in support of advancing clinical research and new drug therapies is reflected in everything we do.
Our highly trained CRO team includes regulatory affairs specialists, biostatistics experts, data management professionals, advanced imaging scientists, and a project management team who are dedicated to providing superior service and who understand the regulatory requirements and science behind imaging trials. Together with world-renowned radiologists from our parent company ProScan and our strategic partners at Massachusetts General Hospital, University of Chicago Medical Center and Cleveland Clinic, our global team offers support for everything from study design to regulatory submission, to ensure an efficient and successful trial process and outcome.
And when it comes to technology, our WorldPRO® platform provides full functionality for imaging data management, clinical data management, image analysis, and project management in a 21 CRF-compliant solution. By leveraging user roles and trial-specific configurable workflows, WorldPRO enables our sponsors to reliably and efficiently manage study activities, including query resolution, among all trial participants in a fully transparent solution.
When you choose to work with WCC, you'll find a trusted partner with the talent, resources and technology you need to ensure a successful trial from start to finish.
Intuitive, flexible and easy to use, our WorldPRO platform provides peace of mind to sponsors by ensuring they have complete control over trial data every step of the way.
As the primary platform for coordinating and centralizing all trial activity between you, your investigator sites and WCC, the WorldPRO system helps facilitate the following activities:
The WorldPRO platform is used to help qualify appropriate imaging sites by providing electronic forms for completion and digital upload of test images.
WCC surveys investigator sites to confirm their hardware is technically adequate and complies with the imaging acquisition protocol. Using the WorldPRO system, WCC will test image quality before the study begins using a phantom or test scan, which is submitted and reviewed by a trained imaging technologist or a leading radiologist. With this test conducted and the scan quality confirmed, the site is now ready to participate in the image submission process.
Upload & Tracking
Using the WorldPRO system, sponsors can be assured a secure and easy image submission. As a web-based system, the WorldPRO platform supports both DICOM and non-DICOM image transfers. Imaging data is uploaded directly through the system and can be viewed immediately, along with any additional clinical data such as photography or relevant clinical data. WorldPRO’s electronic tracking forms allow sites to confirm and track submission in real-time from anywhere in the world. Additionally, WorldPRO will automatically notify the operations team when a submission is received and will include the tracking number for submissions sent via courier. Pre-defined edit checks are built in to all electronic forms, helping to dramatically decrease queries.
QC/Query Management & Resolution
Once uploaded and received by WCC, they are reviewed to determine if images are technically acceptable, of sufficient quality or if a query needs to be issued. Managing and resolving queries is secure and easy using WorldPRO. If a query is needed, the system generates automatic notifications via e-mail, fax, and/or text message to the appropriate user -- whether he or she is at an imaging site, WCC, or the sponsor location. This notification can be customized to meet your specific trial needs.
Independent Review Workflows
Whether your trial requires a single radiologist with a single modality, a double-blind read with adjudication with multiple modalities, or simply an image management platform, the WorldPRO system can be configured to meet your specific needs. Complex workflows also support technical pre-measurement and EAC review, without requiring special hardware or in-depth training.
As the most advanced solution for independent review, WorldPRO provides a single sign-on for IRC and EAC reviewers, giving them easy access to:
This information can be accessed remotely giving reviewers the flexibility to review cases wherever and whenever is most convenient for them.
All results are captured in a smart electronic case report form (eCRF) and are available for sponsor review following QC.
Evaluation of the images is done using a secure PACS/Viewer. The PACS and viewer are fully DICOM-compliant and integrated with WorldPRO, meaning images are automatically loaded into the viewer from the eCRF providing added security and audit trails.
Reports can be run directly from WorldPRO and exported in Excel format for easier sorting/filtering of trial-specific metrics.
Standard reports include:
Following QC, sponsors have the ability to review all of the data to confirm accuracy of case records and select which subjects are ready for EAC review. Following EAC review, all data is accessible by sponsors in read-only format and is archived for regulatory review.
Integration of Data for EAC Review
Data transfers from vendors are integrated into a single case record for EAC review. Data can be submitted in ASCII, XML or PDF formats..
EACs: When and Why? Particularly for registration trials with subjective endpoints, 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 (MGH) to provide subspecialty-trained physicians from across departments for reads. From radiology and dermatology to oncology, cardiology and neurology, WCC provides blinded independent assessments by subspecialty-trained, board-certified experts, who are trained by WCC under a uniform system to maximize the precision and accuracy of data interpretation.
Using WorldPRO, WCC performs a digital assessment that collates all clinical data, including radiology, pathology slides, photography, patient feedback and more, in a user-friendly format, for a digital central review and streamlined submission to the FDA. 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 study with subjective endpoints. Specific services include:
WCC works specifically to streamline the assessment process by integrating the critical components of the data management and statistical analysis plans of the overall trial into the EAC process. By allowing sponsors access to 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.
At WCC, our approach to trial control and commitment to data accuracy are the foundation for regulatory services that help our sponsors through the entire process - from initial design and statistical planning to project management that provide maximum transparency and reliability. Having successfully handled imaging studies for FDA-approved drugs in a number of therapeutic indications, our regulatory team will provide you with a wealth of knowledge and experience. From imaging charter development, to regular attendance at key agency meetings, to mock audits – you can count on our team to provide the guidance and experience you need with your submission to FDA, MHRA, and EMEA.
Read more about our regulatory expertise.
Today’s CMOs are tasked with challenging decisions that have a direct influence on the success or failure of a clinical trial. As trials become larger and more expensive, it’s important to work with an organization that can offer the experience and the perspective to guide the project in the best possible direction. When it comes to the imaging portion of your trial, you can rely on WCC to provide industry–leading scientific, technological and regulatory knowledge to complement your objectives and strategies, and your own therapeutic approach. Every project benefits from the oversight and guidance of our own president who offers a specialized, high-level overview of all the components and options for the best possible outcome. Our goal is to help you get the cleanest and most acceptable data points to accelerate your time to market, and our executive team is here to work with you to get you there.
Email a question directly to our president, Dr. Richard Walovitch.
Data accuracy and control are at the heart of everything we do at WCC. That’s why we are considered leaders in the industry when it comes to biostatistics and data management. Today’s trials can be at the risk of challenges such as definition drift, reader turnover, missed or incomplete training, and other factors that affect data accuracy and put your submissions at risk. At WCC, we are setting the bar for the proactive assessment of imaging data so that sponsors can identify potential issues early, and correct them quickly. We provide sponsors with guidance for the entire process including robust training programs, regular monitoring and communication on trial status, intra- and inter- reader variability testing, performance assessments, retraining, and more.
Learn more about our biostatistics and data management services and how we help to ensure data validity and consistency.
When does it make sense to outsource? Oftentimes, it’s not only when you can get a better result at a lower overall cost, but when you need parallel development paths, added capacity, or simply a new perspective. At WCC, we are 100% focused on imaging for clinical trials, and as such can provide the experience, efficiencies and results that add value to your clinical trial process. Our sponsors benefit from a robust technology platform, WorldPro, which dramatically reduces shipping costs and turn-around times, reduces data queries and other time and resource-consuming events, as well as speeds the entire trial process. We’ve worked with the world’s largest biopharmaceutical companies as well as smaller start-ups looking for an end-to-end solution, and we’re able to customize our approach to meet both types of requirements and drive measurable value in both scenarios.
We realize that in order for a project manager to be effective, they need to have control. By providing the maximum real-time visibility into the data and progress of the trial, our WorldPro technology platform can give project managers the control they need to get their jobs done effectively and efficiently. Program managers benefit from WorldPro’s secure and easy image submission via a unique DICOM header-scanning capability that ensures inaccurate or poor data is never uploaded - dramatically reducing time lost to corrections and corresponding queries. Additionally, WorldPro offers real-time trial visibility via a comprehensive web portal that shows activities such as open study queries, image tracking forms, image thumbnails, on-demand reports and more.
Read more about the WorldPro technology and how it helps project managers be more effective.
WCC is a leader in understanding and implementing statistical design and reader training and testing for imaging trials, and we execute on all plans to provide the most accurate and reproducible data possible. From advanced technology to reader performance monitoring and sophisticated data management capabilities, WCC delivers a new level of control to imaging studies to ensure evaluation validity and ultimate FDA submission preparation and submission.
This effort requires an aggressive program of training and testing for the IR that starts with the selection of the correct review team and lead reviewer: subspecialty, board-certified experts with significant clinical experience.
WCC develops clinical and statistical criteria to demonstrate proficiency of all proposed readers prior to their assignment to the trial, and once the full team is established, sets goals for performance. Consistent monitoring of reading results includes:
To maintain our focus on consistency and precision throughout the trial, our inter- and intra-reader agreement testing allows us to assess reproducibility on randomly selected cases. Readers participating in a study are sometimes asked to complete a blinded re-read to check for consistency, and multiple images may even be tested by multiple readers to confirm consistency between IRs. By conducting both tests, WCC promises active monitoring of readers’ potential variability.
Complementing our inter- and intra-reader agreement is score frequency monitoring. By evaluating reader-specific scoring frequencies and comparing it to both expected frequencies and the mean frequency of the group, WCC can obtain an indication of reader accuracy. For this reader evaluation, we statistically assess heterogeneity across readers using all reads from the trial. The end result is an identification of readers that may be under-calling or over-calling a disease.
Retraining is most often done for the whole group of readers when WCC finds high levels of variability in the diagnosis of results. Here, tough and important cases that have already been viewed are reintroduced into the reader queue to provide more confident estimates of reader variability than randomly selected images.
With a cutting-edge focus on 3D imaging and the aim to improve reader precision in recognizing signs of efficacy as early as possible, WCC works every day to further hone its scientific approach to imaging and deliver best-in-class radiology reviews to sponsors.
WCC has a breadth of experience in every major imaging modality used in clinical trials for the development of therapeutic compounds and medical devices. Recognized as world experts in MR, CT, and PET, WCC radiologists include Level 3 cardiac readers and designated PET readers for the highest-quality interpretations in a trial of any disease state. Additionally, all WCC trial radiologists are trained in a specific therapeutic subspecialty and hold advanced modality expertise in CT, MR, ultrasound, PET, and nuclear medicine.
With unparalleled radiology excellence and a strong emphasis on imaging study quantification, WCC works consistently to develop and improve imaging analysis solutions to increase the precision and accuracy of imaging interpretation. Our associate director of quantification and 3D imaging Dr. Xiaozhou Ma brings an advanced expertise in quantification of clinical imaging studies and 3D image analysis to the trial management team, and our utilization of 3D modalities is a critical part of our drive to refine the science of imaging. With an increased focus on 3D analysis for early-stage oncology and CNS studies in particular, WCC is providing sponsors with critical imaging data at improved precision for a variety of therapeutic indications.
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That’s because we’ve established long-standing relationships with many of the world’s leading medical institutions, bringing more than 100 sub-specialty radiologists and extensive technology expertise for managing high-volume trials right to your fingertips.
Our board-certified, in-house radiology staff is complemented by our strategic relationships with world-class radiology groups, including our own parent company, ProScan, as well as Massachusetts General Hospital (MGH), University of Chicago Medical Center (UCMC) and Cleveland Clinic.
We draw our extensive global technology expertise and teleradiology capabilities from our parent company ProScan Imaging. As one of the world's most trusted and experienced radiology providers, ProScan enables us to manage virtually any volume of images for our trials, while evolving our service offerings and expanding our global reach as the imaging industry grows.
Through our cross-department relationship with MGH, we’re able to draw from the best independent readers in the world for imaging studies and beyond by offering our sponsors access to subspecialty-trained physicians from across departments, who have world-class therapeutic expertise in multiple disease states. We leverage our relationship with MGH to provide oncology, pathology and dermatology reviews for sponsors requiring endpoint assessment committee (EAC) reviews.
It’s through all of these relationships that we’re able to bring the best imaging talent in the world to our sponsors. So whether you choose from WCC’s own board-certified, in-house radiology experts; from our extended family of world-class, subspecialty-trained physicians at MGH and UCMC; or your own independent radiologists, you’ll receive the expertise, scalability and resources necessary to manage large volumes of images and keep your trial on track.
Our ProScan Connection
As a member of the ProScan family of companies, WCC leverages the infrastructure of a diagnostic teleradiology network that efficiently processes over 1,000 images per day from 350 sites worldwide using our proprietary WorldPRO® technology. This advanced reach allows us to provide sponsors with access to global therapeutic expertise and the scalability to process any volume of images for radiology review and image archiving.
ProScan is a global leader in operating freestanding diagnostic imaging centers and owns and operates one of the most sophisticated image transmission networks in the world. All of ProScan’s radiologists are fellowship-trained in at least one sub-specialty and bring extensive experience in image interpretation. The ProScan team also provides a superior workflow borne of decades of experience as the oldest privately-held teleradiology practice in the U.S., enabling us to offer an operational advantage for complex trials.
Massachusetts General Hospital Imaging
Since its creation out of Massachusetts General Hospital Imaging (formerly the MGH Department of Radiology) in 1995, WCC has maintained a strategic relationship with the oldest and largest teaching hospital of Harvard Medical School. This access to the vast range of expertise in multiple subspecialties and modalities (including neuroradiology and nuclear medicine) allows us to provide our sponsors with the highest quality medical reads by leaders in many different disease states.
University of Chicago Medical Center
A nationally recognized teaching and research hospital with a history at the forefront of radiological study, UCMC radiologists provide image analysis and interpretation capabilities to global pharmaceutical and medical device clinical trials managed by WCC, and offer special expertise in oncology and neurology for our sponsors.
We have been working with the MGH Department of Radiology for over 18 years and bring a wealth of expertise in executing WHO, RECIST (1.0 + 1.1) and CHESON review criteria. Extensive experience in complex, multi-component trials allows us to simplify our sponsors’ review process and deliver workflow flexibility unlike anyone else in the industry.
Examples of Oncology Expertise
EACs in Oncology Trials
As Endpoint Assessment Committee (EAC) review becomes increasingly important to oncology trials, the resulting study workflows are growing more complex for sponsors. WCC’s advanced project management and trial workflow expertise enables the integration of not only the imaging data of an oncology study, but additional clinical components such as pathology and dermatology reviews for complete subject assessment.
And because our WorldPRO technology system offers sponsors real-time views of the study data over the course of the entire trial, they can confirm the upload and accuracy of all data before final EAC review. This transparency – facilitated by WCC’s advanced workflow design – helps prevent against EAC re-reads that put your data in jeopardy. We work to ensure that all EAC assessments are as complete as possible and can withstand full scrutiny of regulatory review. With WCC, sponsors can expect secure image submissions, total study transparency, and a detailed audit trail. With varying requirements for different oncology studies, WCC provides a flexible framework that is tailored to each sponsor’s specific needs to reach FDA review with confidence in the submission.
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To meet the demands of this complexity for CNS trials, WorldCare Clinical delivers in-house, volumetric assessments and other complex longitudinal assessments. Having advanced 3D imaging expertise and subspecialty readers with skill sets over multiple modalities, WCC provides a wealth of radiological excellence across a range of neurological indications. Furthering WCC’s capabilities, we leverage our relationship with the world-class MGH neuroradiology team to provide detailed radiology review for MS trials, Alzheimer’s, and more.
For Alzheimer’s, WCC has recently launched its full-service diagnostic assessment program for Alzheimer’s disease. This program is based on the model developed by the Alzheimer’s Disease Neuroimaging Initiative (ADNI). In collaboration with physicists, neuroradiologists and clinicians, WCC can provide a comprehensive evaluation of patients from eligibility review through endpoint assessment. In addition the longitudinal evaluation of on-study imaging can include qualitative and quantitative analysis of PET-FDG, SPECT-perfusion, PET-Amyloid imaging and cortical atrophy as determined by MRI.
And thanks to the flexible WorldPRO technology, we can perform all trial assessments within a single platform. WCC uses WorldPRO to support remote reading teams, access large reading teams for significant volumes, and ensure reader consistency via training, testing and performance monitoring for advanced modalities.
No matter the size or science, WCC provides the necessary expertise for CNS imaging trials.
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