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AxxiTRIALS

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

AxxiTRIALS is a fully automated, unified eTMF and site investigator portal that allows regulatory document exchange between clinical trial sites and sponsors.

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BioVisualization

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

Our BioVisualization service is designed to query our clinical sample databases in real-time, so your most current data is being examined. The figures are downloadable for ease of sharing with colleagues and incorporation into reporting documents.

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Phase I Clinical Research Facility

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

With a highly focused staff/subject ratio, custom-designed facility for cardiac safety, and enhanced data collection processes, Spaulding Clinical is truly in a class of its own.

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Goes Direct Approach

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

The Goes Direct approach allows you to focus on your patients and keeps them under your direct care.

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Monitoring for Clinical Phases Studies

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

We provide standard operating procedure (SOP)–guided study monitoring, auditing, and quality assurance support for all phases and inpatient/outpatient studies at over 50 clinical sites for the biopharmaceutical industry and the National Institutes of Health.

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ERT eCOA

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

We built more than 40 years of scientific and technical experience into our eCOA environment. Streamlined workflows and regulatory adherence make ERT eCOA easy to use with less burden for both sites and patients.

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Clinical Project Management

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

With custom solutions for early- and late-phase clinical trials and a team of highly experienced project managers, DZS Clinical Services ensures that your projects are completed on schedule and within budget while complying with international quality standards.

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Clinical Monitoring

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

The successful execution of your clinical trial hinges on the people involved day to day.

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OnQ Portal- Track Your Study

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

The OnQ Portal™ helps you track your study through the IRB review process, from submission to approval documents

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Services for Traditional Methods

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

With our long history of serving the pharmaceutical industry, Merck has pioneered & refined ground-breaking solutions, demonstrating the regulatory & technological expertise to make compliance as simple as possible, and help save your valuable resources.

Clinical trial monitoring team ensure protocol and regulatory compliance and timely submission of high-quality data. Team consist of registered nurses to doctors, bringing vast therapeutic background and experience. Each monitor is experienced and trained in FDA regulations, ICH guidelines and GCP compliance. Therapeutic focus is on areas like oncology, neurology and infectious diseases, respiratory system and allergies to pain management and metabolic diseases. Quality focused and affordable Clinical trial monitoring services like: full monitoring-services, on-site and remote, site visits (Site feasibility assessments, site selection, site qualification and initiation visits, initiation visits, Budget and contract negotiations with sites, interim monitoring visits, ongoing site monitoring & management, Remote monitoring via EDC, 100%, Targeted or Risk Based monitoring, Electronic Trial Master File management (eTMF), Clinical Trial Vendor Management, close out - study termination visits ), Source document review, Regulatory document review, source data verification, check of study lists and documents, ISF set-up and maintenance, investigator identification, training of site staff, site staff gcp and protocol training, planning investigator meetings, regulatory document collection, review & management, monitoring compliance with ICH-GCP, study protocol and regulatory requirements, Management/facilitation of IRB/EC submissions, conduct of interim analyses, investigational product accounting, blinded and unblinded IP accountability monitoring reports and follow-up letters, Sponsor Expectation to provide high Quality of data retrieved, Tracking of Query resolution process, Study logistics management, Study drug and non-drug supplies logistics, Tracking regulatory document revisions, Tracking protocol deviations/violations, Tracking subject progression, Product accountability, Providing input into the study protocol, informed consent forms, project risk assessment, training investigational sites and study teams, supporting investigational sites with queries around eligibility, safety etc., reviewing SAEs, coding of SAEs and writing safety narratives, reviewing patient data to identify trends and risks across the study, Report generation. Straight forward outpatient studies to large complex in patient studies complying to ICH GCP guidelines and local and international regulatory guidelines. Feasibility through site closeout to support clinical trials around the world. Clinical services are tailored to your needs, complimenting product development plans and overarching corporate and quality management policies. All monitoring activities are conducted in accordance with the study protocol, clinical monitoring plan, standard operating procedures, ICH GCP, and applicable regional regulations. Clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites & conduct on-site monitoring visits throughout the study to oversee data collection, review source documentation and case report forms, ensure regulatory compliance, resolve data queries, conduct interim analyses as requested by clients. Clinical Research Associates (CRAs) ensure the integrity of the study, adherence to protocol, quality of measurements, safety of Subjects, and the collection of valid data. Global monitoring and site management solutions to clients via international team of experienced professionals. Clinical Research Associates conduct clinical monitoring for clinical phases studies, recording observational studies & registries.

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