JANIX is an efficient, metric based clinical research organization (CRO) offering a full suite of services to support biopharma and medical device companies across all developmental phases of the regulatory approval process.

Our mandate recognizes the need within the medical research community for quality clinical services backed by experience, ICH/GCP training, protocol adherence, and leadership while imparting significant cost advantages.

Our expertise spans across the functional areas of clinical trial management & monitoring, medical monitoring & pharmacovigilance, data management & biostatistics, medical writing & regulatory affairs, patient reported outcomes research & marketing studies, and clinical operations development consulting.

We represent a vertically integrated solution to conducting clinical trials and navigating the regulatory approval process by providing a collaborative and highly personalized approach to meet sponsor requirements in a manner that sets us apart from most clinical research service providers. 
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JANIX’ Strategic Vision and Capacity Building in Clinical Operations New Services Directed at the Emerging Growth - Start-up to Mid Stage Biopharma Company

JANIX has devised a new series of solutions and strategies to assist in building a robust foundation for the emerging growth and early to mid-stage biopharma companies requiring expansion in clinical trial execution capabilities, a need to integrate teams across functional areas of expertise, increase infrastructure capacity, build efficiencies in human resource management, general SOP development & implementation of clinical operations support, and create a strong and transparent interface with regulatory agencies to commence and sustain clinical drug development.

We advance the tools and capable personnel to build a fully resourced and functional clinical operations capacity to accelerate the regulatory approval process successfully and within aggressive budgetary frameworks.
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JANIX Operated EDC System—Capabilities

JANIX announces the launch of a new Electronic Data Capture (EDC) system offered in parallel with a Clinical Trial Management Software (CTMS) system which provides a real time assessment of the key variables characteristic of a trial’s progress.

The database, built and validated to meet all 21 CFR part 11 compliance standards, offers extended functionality and integrated features to facilitate and streamline all aspects of the data management process. The days of prohibitive costs are over and cost savings is rewarded to those that toss aside the paper and rid themselves of double data entry. Accurate, Functional, Expedient, and Economic, all attributes of JANIX and our new EDC system.
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The Clinical Study Manager (CSM) is a lynchpin between the Sponsor and the Clinical Research Management and Monitoring team.

At JANIX they are held account for all project deliverables and tasks, and via our rigorously defined and quantitatively validated series of metrics -designed on a study to study basis, is responsible for the Measure of Success and associated milestones within the project. They are tasked to ensure resources are properly committed within scope, quality standards are upheld, time and cost constraints overcome, and regulatory requirements met to make each trial a success.

This critical role at JANIX is supported by first hand experience and bolstered by an unparalleled level of training to produce a dependable and seasoned CSM who will impart strategic vision in conducting a clinical study.
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