Informed Consent and Regulatory

Designing protocols and consent templates that fit current regulation and trial specifications is one thing. Designing protocols and consents for the unspecified needs of the future is another. Partnering with GSS gives you the global knowledge and experience needed to improve collection rates with broader consent and long-term compliance.

GSS manages the needed trust and relationships with ethics committees around the world, as well as the evolving body of global regulation key to protocol design. GSS builds robust, compliant, actionable specimen pipelines for research today and in the future.

Informed Consent Negotiation and Tracking

GSS brings global expertise to the challenges of gaining informed consent for high collection rates with broad consent. GSS leverages its proprietary database of ethics committee behaviors and its patent-pending approach to managing eras of regulatory data for best results. Once consent approvals are reached, GSS tracks consents and links them to specimens being collected under each consent, ensuring all specimens are compliant with active consents during that protocol and beyond.

IC-Codification

Tracking consent templates is just the beginning. Building actionable consent for future research is the key to rapid compliant research. GSS IC-codifies and links all regulatory documents to specimen and assay results, ensuring long-term compliance for specimen and data usage.

Regulatory Compliance

The global regulatory landscape for managing specimens and specimen data is rapidly changing. Compliance is critical. Top specimen research requires the ability to globally access compliance data in real-time. GSS gives you the power to access and manage your pipeline data with peace of mind and a quick understanding of future regulatory compliance.

Return of Research Results

Conducting research around the world is changing. Many countries now embrace the idea of returning research results to patients. Legal jurisdictions are often crossed when conducting research globally, requiring both a plan and a way to deliver research results. GSS solutions automatically process and manage return of research results, ensuring regulatory requirements are met, tracked and managed with little time or effort.