History of Accomplishments

We have successfully completed various cutting-edge projects for some of the worlds largest pharmaceutical companies as well as some of the leading biotech companies. Some recent examples include:

Cell & Gene Therapy Platforms

Implemented solutions for both Autologous and Allogeneic use cases for trailblazing biotech companies.

  • SpagsCorp built solutions on the Salesforce platform for multiple cutting-edge biotech companies to manage the entire treatment process from needle to needle for both clinical and commercial applications of autologous and allogeneic treatments.

    The solutions provided an interface and visibility from patient registration through patient infusion. Unique Chain of Identity (COI) numbers are generated at registration that follow the patient through the entire lifecycle ensuring donor material and final product are always associated with the correct patient. Chain of Custody (COC) is strictly monitored throughout the entire process with the option to generate a COC report at any point along the way.

    Hospital and Clinical Site personnel access the system through custom portals built on Experience Cloud and are presented with all relevant information in real-time. Manufacturing site personnel access the system through a manufacturing portal, also built on Experience Cloud, where they can track manufacturing milestones, enter quality data, print labels, scan containers, etc. Employees of the biotech companies are considered power users and access the system through robust Health Cloud interfaces customized to their needs.

    Specialized interfaces and abilities were provided in Health Cloud and the portals depending on the persona of the individual logging in. Integration with couriers provided near real-time tracking of donor material and final product while in transit. The application also captured the final disposition of the product.

Virtual
Clinical Trial Management Platform

Utilized in leading Covid-19 trials for a top Human Data Science company.

  • Utilized in leading COVID-19 trials on the Salesforce platform for the largest global human data science company that acts as a virtual clinical trial management system (CTMS). This unique virtual CTMS revolutionized the way trials are managed, with the system providing the ability to run global clinical trials virtually, and in turn, increasing subject retention and reducing trial cost for the sponsor. Separate Experience Cloud custom portals were provided for patients and health care providers to access the system.

    The virtual CTMS can support trials that are entirely virtual, entirely in person, or hybrid trials. The solution handles all aspects of a clinical trial including: patient recruitment, registration, prescreening, randomization, patient appointment scheduling, shipment of 10” tablets to the patient for virtual appointments, patient reimbursement, PI payments, separate kits containing investigational medicinal product (IMP), medical technology (MedTech) devices, and lab specimen collection equipment—all shipped to the patient’s home. Additionally, the scheduling of nurses, phlebotomists, and lab techs for home visits, return shipments of unused IMP for drug reconciliation, collection of electronic clinical outcome assessment (eCOA) and electronic patient-reported outcomes (ePRO) are also set up and managed by the virtual CTMS.

Drug Safety and Signal Detection Platform

Utilized by the big pharmaceutical companies to ensure global compliance with Health Authority's safety reporting regulations.

  • Built solutions that sit on the Argus Safety platform for several top 10 pharmaceutical companies to satisfy pharmacovigilance initiatives and fulfill periodic, aggregate, and annual reporting requirements mandated by global health authorities.

    The solution mines the Argus Safety database and provides custom formats for the Investigational New Drug (IND), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Safety Update Report (PSUR) reports.  Users can configure all aspects of reports including report parameters and tabulation algorithms.

Periodic Reporting on Argus Platform

Implemented for a leading pharmaceutical company to assist in drug development and R&D.

  • SpagsCorp implemented a signal detection system build on Empirica Signal to detect, qualify, manage, and report on adverse events (ARs) and Severe Adverse Events (SARs), which allows the pharma giant to enhance risk management and fulfill pharmacovigilance priorities.

    The system provides a graphical intuitive interface for users which is easily tuned by allowing the user to configure and tailor Standardized MedDRA Querys (SMQs) to help avoid false positives and reduce false negatives. Integration with the company’s existing Argus safety platform was provided to always provide the latest Medical Dictionary for Regulatory Activities (MeDRA) updates.