BioTel Research maintains global alliances and partnerships with leading clinical research organizations (CROs), clinical pharmacology units (CPUs), and central laboratories for cardiac, imaging, and blood pressure monitoring (BPM). Partnering strategies are thoughtfully designed to assist sponsors in obtaining best-in-class services, while minimizing any conflicts of interest.
Since 2008, AG Mednet has been the quality partner of choice in over 600 global clinical trials. AG Mednet’s partnership with BioTel Research has resulted in projects with significantly reduced data queries, reduced burden on investigator sites, and increased site compliance. Our managed, global network ensures that all constituencies involved in a project are working in unison and have access to data and records in a timely fashion. Data integration with BioTel Research’s clinical trial management systems ensures that data only needs to be entered once, and that reconciliation of imaging and cardiac safety data occurs in real time. Currently, AG Mednet collects and delivers more than 40,000 exams per month coming from thousands of investigators and trial coordinators in more than 70 countries.
AMRA is the first in the world to transform images from a rapid, 6-minute whole body MRI scan into precise, 3D-volumetric fat and muscle measurements. AMRA’s cloud-based analysis service offers precise, automated insights that have far-reaching implications for the pharmaceutical industry, academic R&D and, soon, clinical practice. AMRA was founded in 2010 as a spin-off of the Center for Medical Image Science and Visualization (CMIV), the Department of Biomedical Engineering (IMT) and the Department of Medicine and Health (IMH) at Linköping University, Sweden.
Cardiac Safety Research Consortium (CSRC)
As a founding member called Cardiocore, BioTel Research was the first cardiac core lab to join the Cardiac Safety Research Consortium (CSRC). Other founding members include pharmaceutical organizations such as AstraZeneca, Daiichi-Sankyo, Eli Lilly, GSK, J&J, Pfizer, Merck, and Roche. The CSRC represents a key initial step in bringing together key constituencies to focus on cardiac safety issues during the drug development process. Using the principals of the FDA’s Critical Path Initiative, the CSRC focuses on improving the evaluative sciences, specifically in relation to cardiac safety.
BioTel Research is the Covance ECG preferred provider for late phase studies and an approved qualified imaging vendor. Covance Inc., a global contract research organization (CRO), is the world’s most comprehensive drug development company. Dedicated to advancing healthcare and delivering Solutions Made Real® by providing high-quality nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development. Because of their broad experience and deep knowledge, they’re in a unique position to provide insights to our client partners that go above and beyond testing.
DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita HealthCare Partners Inc., uses its extensive, applied database and real-world healthcare experience to assist pharmaceutical and medical device companies in the design, recruitment, and completion of clinical trials, including retrospective, prospective, and pragmatic trials. DCR has two hospital-based clinical pharmacology units with 122 beds, and has conducted Phase I-IIa trials for more than 175 client companies over the last 30 years. DCR’s Early Clinical Research group conducts trials in both healthy normal volunteers and specialty populations, with expertise in renal and hepatic clearance studies. Their integrated clinical data analysis and reporting and onsite compounding pharmacies make them a comprehensive service provider for early clinical research.
Global Clinical Trials, LLC is a regional CRO, headquartered in Princeton, NJ, with full-service clinical operations in Russia, Ukraine, Bulgaria, Serbia and Romania. GCT has been performing clinical research in this growing and dynamic region since 2001, providing individualized approaches, flexible pricing, fast patient recruitment, and high quality clinical development services. Whether you are looking for full clinical support, including site selection, monitoring, project management, regulatory services, import/export, drug storage, or medical writing, or you are simply interested in a stand-alone task to address an urgent need, you can count on GCT to handle your requirements professionally and completely. GCT offers a strong understanding of both local and international regulations, as well as access to thousands of qualified sites specializing in numerous therapeutic areas. Our monitors and project managers are all certified clinicians experienced in GCP clinical research. GCT maintains strong ongoing relationships with investigators as well as officials in each country’s regulatory authorities, enabling us to monitor changes in governmental regulations and any related impact on clinical research.
The Mortara Certified Partner program provides expert HL7 consultation to certify adherence to the HL7 annotated ECG standard used by the FDA for collection and viewing of digital ECG studies. The certification process involves validation testing of sample annotated ECG files, followed by detailed consultation on potential syntax and format errors. Upon successful correction of any issues, Mortara provides the Certified Partner a certification letter stating adherence to the HL7 standard.
Myrian is a multimodality platform that processes, combines and compares medical images obtained from all types of imaging equipment (CT scans, MRI, PET, digital radiography, etc.) — all in the same work space and with ergonomic comfort. Myrian optimizes productivity for radiologists and practitioners, making diagnoses more accurate and objective, while facilitating rigorous reading and analysis of medical images in clinical trials.
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 13,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.
PRA Health Sciences provides innovative drug development solutions across all phases and therapeutic areas. But innovation just for the sake of innovation isn’t why they do it. Side by side with their clients, they strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. They help change people’s lives for the better every day. It’s who they are. Innovating to help people is at the heart of PRA Health Sciences process.
Precision Image Analysis (PIA)
Precision Image Analysis (PIA) is an innovator in medical imaging post-processing for both research and clinical applications. PIA offers this cloud-based service for most imaging modalities, including cardiac magnetic resonance (CMR) and cardiac computed tomography (CCT).
With a combined experience of over 60 years of multi-center, multi-national clinical trials and academic-based research, PIA’s technical team has processed thousands of CMRs, CTs and echocardiograms from centers around the world. PIA’s analysis protocols are designed to maximize both accuracy and reproducibility, with quality being comparable to the most precise published standards. PIA was recently awarded ISO 9001:2008 certification for its Quality Management System, demonstrating its uncompromising commitment to providing the highest quality services to its customers.
For more than two decades, QuantifiCare has been developing and marketing innovative imaging solutions for clinical trials and physicians. QuantifiCare is a global company specialized in 2D and 3D photography of the skin. QuantifiCare started as a responsive full-services CRO for imaging. Over the years, QuantifiCare specialized in skin evaluation bringing expertise to pharmaceutical, biotech and cosmetic industries. QuantifiCare provides dedicated 2D or 3D photographic hardware and our services include image procedure definition, Investigator training, image centralization, real time quality check and query resolution follow up. We can also provide tools for central image readings or quantitative measurements services based on the photographs by including accurate measurements.
RadMD was co-founded by Richard Patt MD and Kohkan Shamsi MD, PhD, radiologists with more than 40 years combined experience in pharmaceutical, biotechnology, and medical device clinical development and medical affairs activities. RadMD provides services focused on imaging in clinical trials including expert consulting, independent reviewer sourcing, training, certification, and performance management. RadMD’s exclusive group of >600 readers include radiologists, oncologists, cardiologists, pathologists, dermatologists, and other experts to perform independent imaging and data reviews. All reviewers are trained by our sister company CME certified BRITI (Blinded Readers and Investigator Training Institute), are sub-specialty fellowship trained, and have a minimum 5 years clinical experience.
Vitalograph is a world-leading provider of outstanding quality cardio-respiratory diagnostic devices, with over 50 years’ heritage. Providing a variety of products and services to customers in clinical trials, primary care, occupational health, sports medicine, asthma management, emergency services and hospitals, our name is synonymous with spirometry around the world. As a result of this success we have recently expanded our range of products and services to include innovative solutions for the capture of cardiac data both at home and in clinic.
Worldwide Clinical Trials provides drug development solutions to the biopharmaceutical industry. We support our clients by delivering quality results – on time, on budget and always bolstered by unrivaled science and medicine.