Slope provides the Biospecimen360 platform, an end‑to‑end software suite that captures and synchronizes biospecimen metadata from collection through logistics, processing, storage, and laboratory receipt. The system automates kit inventory, tracks specimen lifecycle with audit‑ready timestamps, detects discrepancies, and integrates with EDC/LIMS to support ICH E6(R3) compliance and real‑time visibility for sponsors and sites.
Funding
Funding not disclosed
Founders
Product
Problem
Complex clinical trials generate large volumes of biospecimens that must be tracked across multiple sites, labs, and logistics partners. Disconnected processes lead to delayed or missing sample metadata, manual data entry errors, and difficulty maintaining regulatory compliance. Sponsors and sites therefore lack real‑time visibility into sample status, risking data quality and study timelines.
Solution
Slope offers the Biospecimen360™ platform, an end‑to‑end software suite that captures sample metadata at the point of collection and synchronizes it across logistics, processing, storage, shipping, and laboratory receipt. The system automates kit inventory management, tracks each specimen’s lifecycle, and provides instant alerts for at‑risk or non‑compliant samples. Integrated data reconciliation tools reduce manual entry, resolve discrepancies promptly, and support ICH E6(R3) compliance. Slope’s professional services extend the platform with custom workflow development, query management, and final database lock support, enabling sponsors to make data‑driven decisions throughout the trial. The combined software and services improve data quality, accelerate study closeout, and lower operational waste.
Target Audience
Primary customers are pharmaceutical, biotech, and CRO sponsors running complex multi‑site trials, as well as clinical research sites that require coordinated biospecimen logistics and compliance reporting.
Features
- Real‑time capture of sample metadata via web‑based forms and mobile interfaces, linked to each kit and specimen ID
- Automated logistics and inventory control that monitors kit availability, shipment status, and storage conditions across sites
- End‑to‑end specimen tracking with audit‑ready timestamps, chain‑of‑custody logs, and secure, HIPAA‑compliant data storage
- Discrepancy detection engine that flags missing, delayed, or non‑compliant samples and triggers corrective workflows
- Data reconciliation module that consolidates vendor data, manages queries, and supports final database lock documentation
- Configurable dashboards and alerts for inventory shortages, high‑priority samples, and recruitment/retention impacts
- Customizable data workflow development and integration services, including API connectivity to EDC, LIMS, and CRO systems
- Professional services package offering setup, optimization, and ongoing support tailored to sponsor or site needs