Ethical Considerations and Clinical Study Compliance

Discovery Life Sciences, Ethical Considerations and Clinical Study Compliance

Discovery Life Sciences, Inc. is committed to following the highest ethical standards possible when conducting clinical research and fully complying with all local, national and international regulations and guidelines. The ethical standards we are dedicated to achieving are clearly described in our DLS Bioethics Policy and you are welcome to receive a copy by simply calling or sending us an email. As a highly specialized Biomarker clinical research organization, we have the capability to respond quickly and efficiently to our Medical Device and Biopharmaceutical industry clients without sacrificing our quality principles and maintaining the full protection of our research subjects. We believe strongly in the work we do and demonstrate this to our clients by maintaining superior client relationships and offering the highest level of professional conduct. Our team is passionate about the services we provide and are committed to treating our research partners and collaborators fairly, respectfully and honestly.

For all clinical research activities, Discovery Life Sciences utilizes Institutional and independent Investigational Review Boards (IRBs) and Ethics Committees (ECs) that are in full compliance with Federal Regulations 21 CFR parts 50 and 56 and in accordance with regulations described in DHHS 45 CFR 46, 160 and 164, and the Health Insurance Portability and Accountability ACT of 1996 (HIPAA). All IRBs are registered with the Office for Human Research Protection (OHRP) and comply with standards outlined in up-to-date ICH guidelines. All of our IRBs are pursuing or are accredited by AAHRPP. Our biorepository is compliant with all HHS/OHRP, ISBER and NCI/BBRB regulations, guidelines and best practice procedures.

In addition, IRBs follow the research principles adopted by The Declaration of Helsinki and all other applicable (U.S.) State and International statutes and guidelines. We work continuously with our sites and investigators to ensure, as a team, that studies are conducted ethically and in full compliance for all regulatory submissions.

 

Magellan

An Open Access Biobank Enabling Novel Biomarker Assay Development.

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DiscoveryTrak

Biosample Program Management, Packaging, Distribution and Logistics.

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Discovery Partners™

An Experienced Network of Principal Investigators.  Worldwide.

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ValidateNow™

Customized Product Launch Kits and Reference Panels.

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