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LIFE SCIENCES PRODUCTS
AND PLATFORMS

Calsoft optimizes your development timelines to get medicines and medical devices to market quickly using next-generation clinical trial platforms based on Digital Transformation by Big data, Analytics, and AI integration.

dSafeR 

PHARMACOVIGILANCE DATABASE

DRUG SAFETY APPLICATION

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dSafeR Safety is a cloud-based, user-friendly, easy-to-use, regulatory-compliant end-to-end Pharmacovigilance / Drug safety system. The all-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety Signals capabilities under one platform.

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Patients' safety is given prime importance for ongoing medical support at the site. Serious Adverse Events and Adverse Drug Reactions are all monitored, documented and reported within the defined timelines. Our team consists of several Physicians and Doctorates in Pharmacology with experience in Pharmacovigilance practices for trials across a wide array of therapeutic indications.

  • Providing medical monitoring/support to sites

  • Serious Adverse Event (SAE) Management

  • Assessment of Causality and Expectedness of Adverse and Serious Adverse Events

  • Preparation of Alert letters

  • Medical Writing Authoring of clinical study documents (Protocol, Investigators Brochure, Summary reports and Publications and authoring of medical communications

  • Our team consists of several Physicians and Doctorates in Pharmacology with experience in medical writing for trials across a wide array of therapeutic indications

 

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​CTMS  is a cloud based, highly configurable, "end-to-end platform which" helps manage all aspects of clinical trials including :

  • Site Monitoring Visits

  • Milestones - Planning and Tracking

  • Activities - Tasks  & Deviations

  • Payments - Site & Investigator

  • Investigational Product (IP) Tracking &  Inventory (IWRS)

  • Patient Recruitment & Randomization (IWRS)

  • Patient Visits - Scheduling and Tracking

  • Site Selection, Site Initiation, Investigator Selection

  • Master Data Management (Sites, Investigators)

  • Regulatory documents & Compliance Tracking

  • Study Budgets & Training Management

  • Adverse Event Tracking and many more.

  • ​CS- Clinical Trial Management System (CTMS) meets the regulatory guidelines including security, access control, change controls, audit trails, and system validation.

CS- CTMS 

Clinical Trials Management System

Clinical Data warehouse and Analytics Console - CLIDAC is a secured, regulatory complaint Clinical Research Data Warehouse and Analytics System.

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  • CLIDAC provides solutions with fact-based insights into clinical trial data, in order to assist your organization making informed business decisions, thereby helping your organization in increasing productivity and developing drugs in an effectivemanner, at a faster pace.

 

CLIDAC helps in

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  • Standardization including SDTM transformation

  • Data reconciliation

  • Ongoing medical review

  • Safety monitoring and signal detection

  • Cross-study analysis

  • Single data storage for data mining and visualization

 

CLIDAC Automation and AI platform is designed specifically for the clinical trial enterprises. It applies advanced automation & AI algorithms to reduce man power, improve performance and save time. Notifications and follow-ups can be generated automatically without any human intervention using configurable workflow engine.

CS-CLIDAC  

Clinical Data warehouse

and Analytics Console 

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