Delivering Regulatory Compliant GxP Technology Solutions For Biopharma and MedTech
Techsol offers fully-managed GxP Technology platforms and related managed services for emerging Biopharma and Medical Device companies using the SaaS model. Clients can leverage our integrated system deployment models to manage business processes and GxP data to increase quality and operational efficiency.
Our System Integration Services
- Knowledge Support for Business Processes Change Management
- Configurations Discovery and Process Simulation for Business Use Cases
- GxP Systems and Source Data Migration with Testing and Qualification
- Cross-functional System Integrations Setup, Testing & Deployment
- Process-oriented Business Reports & Analytics Services
Increase Quality, Compliance and Productivity with our Powerful Safety System Integration Services
Establishing a streamlined Global Drug Safety and Signal Management system requires an integrated approach and a close-knit collaboration and communication between various functional groups. Pharma companies and Pharmacovigilance team members face a multitude of challenges with disconnected systems and manual processes to address key compliance challenges and operational oversight requirements.
With our technical and functional domain expertise in Drug Safety, we have successfully enabled clients to send safety case information such as adverse events and serious adverse events from external systems to Argus safety for case booking and electronic submissions to regulatory bodies.
Medical Information System and Argus Integration
Adverse Events reported by Healthcare Professionals (HCPs), Caregivers, and Consumers can be easily processed in Medical Information Systems like MedInquirer and transmitted electronically to Oracle Argus Safety.
With a bi-directional integration, the Medical Information team can automatically get acknowledgment receipts from Oracle Argus to MedInquirer.
How We Do it
- Complete Adverse Event E2B XML field mappings between MedInquirer and Argus Safety
- Define AE Transmission Rules based on one or more conditions
- Set the integration path using a E2B Gateway server or by using a SFTP folder setup
- Map the fields between both systems for receiving acknowledgements when the AE gets ‘Accepted’ or ‘Rejected’ in Argus
- Auto-populate the Argus Safety Case ID in MedInquirer
Oracle Argus and Inform Integration Services
Clinical Trial Sites can directly report Adverse Events to both the Data Management and Drug Safety Teams by establishing the Oracle Health Sciences InForm and Oracle Argus Safety integration. This helps to increase productivity and most importantly companies will never miss a deadline to timely report and process clinically significant adverse events.
How We Do it
- Identify the data points in Central Designer Logical Schemas that need to be sent to Argus Safety
- Define which data should trigger a follow-up to safety if the data is changed.
- Potentially related adverse events, labs, and concomitant medications are sent to safety based on time frames you configure.
- If desired, the Argus Case #, whether the safety user accepted or rejected the E2B file, and the rejection reason can be sent back to InForm.
Service FAQs
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.
