Rules-Based Medicine Rules-Based Medicine (RBM) is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from...
The Jackson Laboratory We help researchers discover treatments, preventions and cures for human disease through the provision of inbred, mutant and genetically engineered mouse models, research services, and comprehensive technical information...
Clinlogix, LLC. Global CRO Clinical Trials pharmaceutical biotech medical device vaccine phase I II III IV diversity site patient recruitment safety biostatistics program data management
Site Management
As a Global Clinical Research Service Organization, Clinlogix understands that choosing the “right” Investigative Site with access to the “right” patient...
ProTrials Corporation ProTrials provides clinical operations professionals and services to pharmaceutical, biotechnology, and medical device companies. Founded in 1996, ProTrials enables its clients to cost-effectively conduct clinical trials...
Site Management
Choosing investigators and study centers can be a resource-intensive task. ProTrials’ clients can use our investigator database, or you can outsource the...
Aureus Research Consultants, LLC Aureus Research Consultants targets specialized-areas such as Phase I clinical trials, Oncology site networks, and Investigator-Initiated studies. We also perform audits for those Sponsors assuming INDs from former...
Aureus and Monitoring
Since 1997, Aureus has performed site monitoring services for the drug, medical device, and biotechnology industries. In a segment of clinical operations...
Site Monitor/ CRA Training
Updated in 2009 to integrate the use of Medical Simulation Technology to teach ICH/GCP requirements, our workshops for site monitors continue to “top” the...
ACR Image Metrix ACR Image Metrix foundation is based on the scientific excellence of ACRIN, the NCI-funded clinical trials cooperative group and American College of Radiology (ACR), the premier professional society serving more than...
Healthcare Communications Group Healthcare Communications Group has one specialty—professional clinical trials recruitment services. We help pharmaceutical companies involved in drug development build their subject recruitment plans upon a foundation...
New patient recruitment avenues in clinical trial site selection process: online social networks
Brian Loew, the CEO of Inspire, one of many online social networking sites that bring groups of people together who suffer from the same disease or condition, reports that, “You can’t create a community just about clinical trials.” He says that social networking functions as “a mechanism for attachment.” His company collaborates with many non-profit health organizations and screens the list of members who have volunteered to be trial participants using each trial's inclusion and exclusion criteria.
“For one of the [lung cancer] studies, we already have a community with ten times the number of members who meet the initial inclusion criteria,” says Loew. An additional service provided is quality assurance in which data is collected from participants about their degree of satisfaction with the trial and compiled into a report.
PatientsLikeMe initiated the first “patient-driven, real-world natural experiment” in which large amounts of data was collected in a few months at very little cost. These online studies can provide “credible direction as to when a clinical trial should be conducted. As a result, patients will have a direct voice into what types of research deserve attention and significant investment" in the resulting clinical trials, according to president and co-founder Ben Heywood.
Best-in-Class Trial Site Selection Providers:
A proven track record of efficient randomized patient enrollment
The ability to get up and running quickly and to generate timely, high quality data and reports
Can handle the pharmacokinetics/ pharmacodynamic and other laboratory or radiological studies that support the trial
Top Considerations Before Selecting Trial Site Selection Providers: Clinical trials represent about 30% of companies’ drug development budgets. Due in part to slow patient recruitment and poor retention of trial participants, 75% of trials fall behind schedule, increasing costs. Online social network recruitment may be able to rapidly deliver a larger and more dedicated population. Ask whether the providers you are considering have considered this method.
Key Providers:
1. Rules-Based Medicine, Inc. (RBM), is a trial site provider. RBM, founded in 1998, is the world's leading biomarker testing laboratory. By combining EDI’s cell culture systems with its HumanMAP® biomarker testing services, RBM is able to offer customers a preview of the physiological and biochemical impact of a new drug before the human trial stage begins. RBM has corporate headquarters and CLIA-certified biomarker testing laboratory in Austin, TX; multiplex assay development and manufacturing in Lake Placid, NY and a wholly owned subsidiary EDI GmbH in Reutlingen, Germany. Through EDI GmbH, RBM provides Human Organo-Typic (HOT) cell culture systems which serve as a platform for ex vivo drug safety and efficacy studies.
3. The Jackson Laboratory is a trial site provider whose services include testing numerous medicinal entities, including small molecules, antibodies, siRNAs and ES cell-derived therapies, as well as customizable compound evaluation, phenotyping and pathology services. This company is an NCI-designated Cancer Center that uses mouse genomics to discover ways to prevent cancer as well as to discover drugs to treat conditions including: cancer, diabetes, Alzheimer’ and cardiovascular disease. In addition to conducting genetic research, this independent, nonprofit organization provides scientific resources, techniques, software, data and mice colonies for test animals to scientists in research institutions and laboratories around the world. Jackson Laboratory scientists are engaged in collaborative research with organizations around the world.
4. ASKA Research offers a full range of clinical trial monitoring services from project conception to final approval, including Project Management which involves managing all aspects of the trial like site selection and ICF and CRF design. Customers include pharmaceutical, biotechnology and biologics companies, in addition to research organizations that receive federal funds. ASKA reports that "Through one point of contact, you have access to our Research Professionals Network (RPN) of established clinical research professionals, our collaborative partner organizations, and our CRO alliance partners in the United States, Europe and the Asia-Pacific region."
5. Global Research Services offers consulting services for clinical trials including Strategies for Accelerating Patient Recruitment which involve its proprietary tools. GRS has access to global patient populations through offices in Rockville, MD; Langenfeld, Germany; Warsaw, Poland; Montreal, Canada; Shanghai, China; Maharashtra India; Rosario, Argentina; and Sao Paulo, Brazil. GRS utilizes all electronic start-up processes, plans and tools including established start up plans, document templates and comprehensive checklists and has international regulatory experience. This private company has over 20 years of experience.
Trial Site Selection Definition: The series of considerations that go into choosing which company will conduct a clinical trial.
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Following publication of the December 2008 FDA Guidance for Industry Diabetes Mellitus— Evaluation of Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,1 assessment of cardiovascular safety has become a critical focus during the development of new antidiabetic therapies for Type 2 diabetes mellitus (T2DM). The importance of this guidance document, referred to from here on ...
There is plenty of discussion in the biopharma industry about declining R&D productivity, increasing development costs, diminishing returns on marketing and sales, and lower earnings. And the “patent cliff” that is quickly approaching will only increase pressure on biopharma players. From 2009 through 2014, an estimated $128 billion of branded revenues will lose patent protection and face generic ...
In its response to the cacophony of demands for cost-effective, innovative medicines, the biopharmaceutical industry has a unique chance to influence the U.S. health care landscape. The traditional model of pharmaceutical R&D in which a steady stream of broadly indicated blockbusters gave market-based rewards is a rapidly fading memory. While products are becoming more targeted to smaller patient ...
Challenge your company to find creative ways to lower your costs with your goals. By optimizing the management of non-core activities you can save money, increase performance and improve workforce productivity.
In the competitive, highly regulated business climate that exists in the life science industry, companies are challenged to find creative ways to lower their costs without compromising ...
StudyManager enables Northeast Arkansas Clinic to conduct 120 clinical trials simultaneously while tracking what it’s being paid, what it’s owed by clinical study sponsors, and how profitable its clinical trial work is.
The cost of developing new drugs has been increasing at an alarming rate – approximately 11 percent per year compared with annual drug sales growth of only 6 to 8 percent. At the same time, drug pipelines have been shrinking, putting even more pressure on biopharmaceutical companies to squeeze more out of what they have. Given the serious concerns over the spiraling cost of prescription drugs, ...
At a time when biopharmaceutical sponsors are feeling intense pressure to increase R&D output, accelerate clinical timelines and reduce development costs, a growing number are moving away from paper-based processes and adopting electronic data capture (EDC). Sponsors are making this choice because once implemented, EDC brings efficiencies to the collection, exchange, analysis, and management of ...
Asset Management Organizations today are under tremendous pressure to increase productivity and efficiency, reduce total cost of ownership, and focus on core business competencies. To meet these business objectives, many are looking to external business partners to manage non-core business competencies, especially in the area of instrument and equipment management, service and support. In today’s ...
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