In true collaborative form, Chiltern is dedicated to establishing strategic alliances with the best clinical research development service providers in the industry. We put the infrastructure in place to make the work happen as effectively and efficiently as possible and to deliver what’s best for your budget, timelines and outcomes.
With every alliance we develop, you gain access to advanced technologies, methodologies and expertise with niche focus areas, and, thus, the ability to fortify your project with the best thought leadership available. Many of Chiltern’s strategic alliances have locations worldwide, which means enhanced service and access for you. Additionally, the model of our strategic alliances makes working with these groups efficient and effective.
For more than 60 years, Charles River has been helping global partners accelerate their research with services spanning the entire drug development process. The company’s high-quality research models, preclinical testing capabilities and clinical support services are backed by a comprehensive bioanalysis portfolio (non-GLP and GLP). Charles River can develop, validate and apply quantitative bioanalytical methods for the determination of pharmaceutical compounds ranging from small molecules to larger proteins. The company’s laboratories have the latest instrumentation to measure drug and metabolite concentrations in biological matrices, such as plasma, serum, cerebrospinal fluid, urine and tissues, using a wide range of techniques and technology platforms. This variety of advanced equipment ensures the capacity and rapid lead-in times needed to meet critical deadlines. Full support for capillary micro sampling and dried blood spot analysis is also offered.
Decision Driver Analytics founder Elizabeth Brooks, Ph.D., has a strong history of designing cost-effectiveness and budgetary-impact models and is considered an expert in her field. DDA was established in 2006 to address the disparity between what health economics firms provided and what medical device, pharmaceutical, biotech and CROs really need — complete product life cycle value analysis. DDA is focused on providing accessible health economics analyses and strategies that can be used to drive strategic decisions from product identification and planning through market communication and cost-effectiveness and value-based financial modeling.
The Decision Driver Analytics team consists of veteran health economists, epidemiologists, biostatisticians, medical writers and reimbursement experts. DDA delivers product and economic insight in the form of actionable data that drives decisions and clearly communicates a product’s differentiated value.
Emergo Group is an ISO registered medical device consulting firm with 25 offices throughout North and South America, Europe, Middle East and Asia-Pacific. The company specializes in helping small to mid-sized medical device and IVD companies gain access to new markets and has assisted more than 3,000 clients in the following areas:
- Medical device registration and approval
- ISO and GMP quality system compliance
- In-country regulatory representation
- Distributor search and qualification
Medidata Medical Imaging, formerly Intelemage, is reducing time, cost and risks by changing the way the industry thinks about the use of medical imaging in clinical trials. Unlike conventional systems that focus only on image delivery, Medidata Medical Imaging considers the entire image management process. This approach leverages the technology to provide configurable, intelligent workflows that complement your users and align to your protocol, and automate key areas like de-identification, edit checks, image routing and workflow management — thus, drastically reducing time, cost and risks in your clinical trial.
RadMD provides imaging expertise to help define, develop and implement imaging strategies in clinical trial programs for pharmaceutical, biotech and medical device companies. The company’s expertise lies in the ability to construct and implement unique and customized medical imaging solutions. Consulting services are led by a team with over 35 combined years’ experience in the use of medical imaging in clinical trials. Specialty therapeutic areas include cardiac safety, musculoskeletal and spine solutions, obstetric ultrasound and radiation oncology.
RadMD offers an array of consulting services; examples include: protocol development — to optimize imaging endpoints — criteria modification, development of site/independent image review strategies and Independent Review Charters (IRC).
In addition to clinical support, the company possesses extensive knowledge and experience in regulatory affairs to provide assistance for all regulatory meetings and submissions related to imaging in clinical trials.
RadMD also provides standardized and customized training for imaging in clinical trials through its training organization BRITI (Blinded Reader and Investigator Training Institute). BRITI has developed training and testing modules on a variety of topics relating to medical imaging in clinical trials and independent evaluations of trial data. These modules were developed by experts with extensive experience in these areas. Training can be provided either online or locally and is available with CME accreditation.
When independent image evaluations (“blinded reads”) are used in trials, it is critical that physicians performing the evaluations have expertise in the disease process. The company’s blinded reader sourcing service matches the most qualified physicians to individual studies, utilizing the largest global network of physicians who have undergone standardized training as blinded readers. This translates into faster image evaluations by the most qualified personnel for trials. The company has a database of over 600 pre-qualified, vetted specialists, including radiologists, cardiologists, oncologists, pathologists, neurologists and others to perform blinded read analyses. Readers are available for safety, efficacy, inclusion evaluations and confirmation of disease progression.
Ximedica is a full-service ISO 13485-certified and FDA registered product development firm with an exclusive focus on medical devices, combination products and consumer health care products. With more than 25 years of experience and more than four times that in patented products delivered, its client base spans the globe and ranges from startups to the world’s largest OEMs.
Healthcare Product Realization
As a trusted innovation partner, Ximedica deploys an integrated, user-centered process that provides clients with design solutions that meet the safety and use needs and requirements of an exhaustive range of populations and environments, thereby minimizing risk during the regulatory review process.
Expertise and Accountability
The company’s deep bench of expertise includes a spectrum of disciplines from research to human factors and usability, testing to manufacture for clinical build and beyond, all within one facility ensuring efficiency, accountability and IP protection.