BCS exists to improve competitive market advantages for our clients. We deliver end-to-end IT and communications solutions that are cost-effective and match your operational needs. We develop lifelong client relationships by eliminating technology-based headaches through scalable solutions from IT assessments to 24/7/365 support. BCS unique qualification to deliver best in class solution is the result of our strong of technology partnerships, deep industry experience and committed staff of over 80 professionals.
ARCC qualified Hosting is an Audit Ready Compliant Cloud Infrastructure for the Life Science Industry that takes complexity, cost and risk out of obtaining, deploying and managing a qualified and validated cloud solution that supports regulatory requirements.
Developed by Strategikon Pharma, Clinical Maestro is an end-to-end elegant cloud-based platform to more efficiently budget, source and manage complex clinical programs. We believe that intuitive technology, complete transparency and effective communication between biopharmaceutical companies and providers will revolutionize the productivity of clinical research. For more information
TrialCard Incorporated pioneered the RxStudy Card, which utilizes the North American network of retail and specialty pharmacies to provide clinical trial patients with unblinded study-related medication and supplies. The RxStudy Card delivers logistical and financial efficiencies to the clinical supply process, saving time while providing improved management of patient safety and adherence. The RxStudy Card allows faster and easier study start up, agility, and affordability and has been trusted in more than 175 clinical trials by pharmaceutical manufacturers, CROs and academia. The company is headquartered in Morrisville, North Carolina.
Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. For more than 30 years, Rho has been a trusted partner to some of the industry,s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience.
AXIS Clinicals is an integrated Pharmacology clinical and bioanalytical contract research organization. Our clinical operations (for a total of 228 beds (48 of which are hospital beds)) and our bioanalytical laboratory are located in the same building in Dilworth, Minnesota. The encompassing operations are ideal for quick turnaround of analysis to support Single Ascending Dose/Multiple Ascending Dose.
Our USA organization expertise encompasses the different facets involved in phase I studies:
- FIH studies: SAD/MAD (either sequential or combined designs),
- Pharmacokinetic/Pharmacodynamic Studies
- Food Effect Studies
- Drug-Drug Interaction Studies
- Age and Gender Effect
- Renal and HHepatic Impairment
- QT/QTC Cardiac Safety
For Regulatory Guidance and Support, Axis Clinicals is able to help you in your clinical development from a start-to-end strategy:
-Strategic Drug Development/GAP Analysis (FDA submissions)
-In-Vitro Study Screen Studies Planning
-Pre-IND Package Development
-IND Package Development
-FDA Advisory Committee Presentation
-PK/PD Modeling and Simulation
-Medical Monitoring/Safety Operations
-Nonclinical and Clinical Study Management
-PK and Statistical Analyses (standard and complex)
-Medical and Scientific Writing
Crown CRO is a privately-owned Finnish contract research organization founded in 2005. We specialize in customer-oriented, competitive, and flexible services for clinical trials in Europe and the United States, with global Data and Pharmacovigilance capabilities. Our contributions to these studies and other research projects help advance medicine and, ultimately, create a healthier future. - Clinical operations - Project management - Data services - Pharmacovigilance - Quality assurance - Regulatory and medical affairs - Translation services - Early development consulting Our success is based on local expertise in regulatory processes, requirements and a wide network of health professionals and institutions. Our people are both dedicated and profoundly clued up on the industry and its processes and challenges.We want to be a partner you can trust and who always sticks to promises. Our team spirit, low staff turnover, and high employee satisfaction brings you a committed team of talents dedicated to tackling your challenges and building a healthier future, together.
TrialStat eClinical Suite - A New Paradigm in Data Management Technology TrialStat delivers data management solutions for pharmaceutical, biotechnology, medical device companies, CROs and Data Management companies. TrialStat consists of three fully unified product offerings - EDC, Portal and CTMS. TrialStat EDC integrates features such as Randomization / IWRS, Medical Coding, ePRO, CTMS and Imaging, along with a configurable real-time reporting analytics portal, with real-time data exports, to simplify trial data collection and ensure efficient and timely analysis in an easy-to-use environment.
With a focus on analytics, TrialStat offers robust reporting and metrics across a single study or your entire research portfolio Ė providing all stakeholders relevant, customized, real-time insight into all aspects of study data while highlighting areas of risk or delays. TrialStatís API and focus on interoperability allows you to take advantage of EMR / EHR Data, Real World Data (RWD/RWE) from validated and non-validated wearable devices, and integrate with third-party systems to provide a comprehensive reporting Dashboard for all of your stakeholders.
Key Features Include: Randomization Inventory Management Payment Tracking Patient Report Outcomes (ePRO) Dynamic Skip Logic Customizable Workflows Comprehensive Edit Checks AE / SAE tracking Image Management Flexible Data Capture Real-Time Monitoring, Reporting & Validation Multi-Lingual Support
Cliantha Research, full-service Clinical Research Organization (CRO), provides comprehensive and integrated offerings in Early Phase, Late Phase, Respiratory, Tobacco Research, Dermatology, Consumer Research, Research Lab, IVRT, Biometrics, Pharmacovigilance & Medical Services, Environmental Exposure Chambers (EECs).
By leveraging on the depth of experience, Cliantha provides ethical, value added customer centric services rooted in excellence, thereby enabling clinical development of pharmaceutical, biotech & healthcare companies.
With strategic acquisitions globally, Cliantha has widened the horizon of clinical research & support services for end-to-end developmental needs all across.
With several advanced clinical sites and bio-analytical laboratories in North America and India, Cliantha now has presence in 4 countries along with a strong team of 1000+ professionals. Some of the key regulators, such as the USFDA, EMA, AGES, ANSM, AMPS, MCC South Africa, Health Canada, DCGI, CAP, NABL, Turkey MOH, Thailand MoPH and others have successfully inspected Cliantha across the globe.
Cliantha Research is headquartered in Ahmedabad and has expanded its domestic reach with 5 regional offices & international presence with offices in USA (Florida & New Jersey), Canada (Mississauga, Winnipeg & Scarborough) & Europe (Portugal).
Intrinsic Clinical Systems is the result of decades of combined drug development and clinical trial experience. Having worked with traditional clinical trial management systems and resource planning tools, we've felt the frustrations that come with the needless features and huge price tags. We heard the industry's requests for cloud-based tools that are affordable, easy to use, and don't require an IT department to manage.
Intrinsic has four cloud-based software products - CTMS, Site Feasibility & Engagement, Resource Management, and Time Tracking. Our tools help biopharma companies more easily manage their trials, resources, and sites, using today's latest technologies. Each module can be licensed separately, or users can enjoy the benefits of an integrated suite of Intrinsic products.
Intrinsic products are built with the end user in mind and leverage technologies that you use every day. Our tools are fully integrated with Microsoft Office & MS Project, and hosted by Microsoft in their Office 365/Azure platform, so biopharma companies can benefit from a robust, secure, and scalable infrastructure. By leveraging native Microsoft functionality and providing end users with a familiar interface, user adoption of Intrinsic tools is never a problem.
Visit our website at www.intrinsiccs.com/ and see the difference for yourself.
NoyMed is a full-service contract research organization (CRO) providing Biometrics, Clinical Operations services to pharmaceutical, biotechnology, and medical device industries worldwide having its offices in Burbank, California and in Yerevan Armenia. NoyMed Services:
-Full spectrum of Data Management services
-Database Design using different EDC technologies
-Statistical Programming - Full CDISC implementation
NoyMed organizes and conducts trials from study startup to close out
delivering FDA/EMA submission-ready packages. NoyMed team is meticulously monitoring
deliverables, timeline compliance for every project and this well-ordered, disciplined approach
to managing the projects reflects NoyMed company-wide commitment to excellence in every
aspect of the performance, allowing clients to trust NoyMed to deliver the highest quality
data on-time and on-budget.
JSS Medical Research is a full-service clinical research organization (CRO) with strong academic affiliations that was founded in the mid-1980s by Dr. John S. Sampalis, a tenured Professor in the Faculty of Medicine of McGill University and the University of Montreal. All senior scientific members of JSS Medical Research have training in clinical research and epidemiology, and are affiliated with McGill University, University of Montreal or Laval University. Through our corporate head office, located in Montreal, Canada, regional hubs in Bogota (Colombia), New Delhi (India), and Warsaw (Poland), and our global network of partners, we can conduct clinical research in North America, Latin America, Europe, the Middle East and Asia. The services offered by JSS Medical Research cover the entire spectrum of clinical research from study conception, design, execution, data analysis and dissemination of results. The staff of JSS Medical Research includes clinical epidemiologists, physicians, biostatisticians, project managers, quality assurance experts, monitors, medical writers and information technology experts. One of our distinguishing attributes is our methodological knowledge and expertise in the design and execution of clinical studies. Globally, JSS Medical Research has conducted over 825 projects. Specifically, within the Americas (mainly USA and Canada), 229 were Phase I - III trials, 63 were Phase IIIb - IV trials, 70 were Post-Marketing Observational Studies or Health Economic and Outcome Research projects, 13 Medical device Studies, and 16 Ministry of Health Regulatory Submissions in the LATAM Region. The therapeutic areas covered in these projects include - but are not limited to - autoimmune disorders, cardiovascular disease, CNS/psychiatric conditions, dermatology, endocrinology (diabetes), gastroenterology, infectious diseases (including HIV/hepatitis), medical devices, pain management and trauma, obesity, oncology, ophthalmological diseases, respiratory conditions, rheumatology (arthritis/OA), transplantation, women's health and vaccines.