SynteractHCR offers full-featured global Interactive Voice and Web Response Systems for your clinical trial operations, through our validated 21 CRF Part 11 compliant proprietary system. Once implemented, the system is available 24/7 for use by sites, study participants and project team members. Transactions are recorded into a study-specific database, and information can be exported into custom reports. Live technical support is available to sites and study participants via phone, email or web access. SynteractHCR has successfully implemented IWRS in 30 countries and has the capability to translate 26 different languages.
Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.
Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.
LabConnect has the laboratory abilities required to meet specialized testing needs around the globe, and has experience in oncology related indications such as breast cancer, lung cancer, and leukemia. Their extensive testing menu includes specialized oncology assays, biomarker analysis, pharmacokinetic analysis, and method development services.
Cenduit Drug Accountability Web-based tracking that closes the paper gaps.
LabConnect’s SampleGISTICS™ real-time tracking service follows specimen samples from collection through logistics to receipt at any lab or storage location around the world. The service offers enhanced visibility of each individual sample, an innovative virtual accessioning process, and immediate query resolution.
LabConnect has the ability to secure and protect customer biospecimens and samples, while ensuring that they retain stable temperatures and chain of custody for sample integrity and regulatory compliance. LabConnect also provides easy sample accessibility for prompt retrieval and shipment throughout the complete sample life cycle.
LabConnect offers the scientific expertise for an extensive array of specialized testing options including oncology assays, biomarker analysis, pharmacokinetic analysis, and method development services. With more than 4,000 validated tests across its global network of central laboratories, LabConnect also provides the project management and client service tools needed for ensuring data and sample integrity.
LabConnect has a laboratory network with more than 25 locations around the world that offers both routine and highly specialized testing, supporting everything from single-site studies to large multinational trials. With over 4,000 validated tests, the network is able to handle everything from general safety testing to extremely complex molecular diagnostics and biomarker analyses.
With study sponsors, regulators and payers focusing more on the value of therapies than ever before, patient outcomes have taken on a new priority.
|
|
|
|
|
|
|
|
|