When considering clinical trial disclosure solutions, it is important to understand the potential partner’s practical experience and how their solution fits your compliance needs today and in the future.
TrialScope Clinical Trial Transparency Service (CTTS) enables clinical trial sponsors to engage with patients and the public via a user-friendly, high impact website to openly share clinical trial information and results, demonstrating leadership in transparency while optimizing trial recruitment and retention.
PharmaCM is a clinical trial disclosure platform designed specifically for the regulated environment of Life Sciences. PharmaCM is used to manage the complex process of authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data. Disclosure content is very dynamic. Clinical trial data is constantly being updated, modified and formatted for specific registries such as ClinicalTrials.gov and EudraCT.
TrialScope Clinical Trial Registry Manager (CTRM) delivers the proven solutions clinical trial sponsors need to centralize, track, register, and comply with clinical trial disclosure processes, mitigating compliance risks while giving them greater control over their own clinical trial disclosure reputation.
CLINICAL TRANSPARENCY
Clinical trial sponsors are required by law to disclose information on their clinical trials in multiple places. These regulatory requirements continue to change as new mandated registries emerge and the scope of disclosure expands. This dynamic scenario creates a challenge for sponsors who must track and manage disclosure content that is being prepared for different registries, with different requirements.
Contracting an in-country clinical depot helps bring costs and timelines under control.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.
With more than two decades of experience providing customized data management services for clinical trials to our clients, SynteractHCR is a contract research organization that has developed a reputation for high quality, cost effective solutions to fit your unique project needs. We know the importance of accurate, timely data management for clinical trials, and that’s why we have implemented the right combination of technologies with the care and insight of experienced personnel. Our clinical data managers have medical and life science backgrounds and as well as specialized programming experience.
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.
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