Center for Global Research Data
Our Members
SpecGx LLC, a subsidiary of Mallinckrodt plc
| About | SpecGx manufactures a portfolio of generic pharmaceutical products, including certain opioid products for pain management. |
| How we share on the Vivli Platform | SpecGx’s studies that are available for data sharing are listed on Vivli. Data requesters should use the Vivli Data Request Form to request data package(s). If the request is approved, SpecGx will upload the de-identified data into the Vivli platform for use by researchers. |
| Studies Listed for Sharing | SpecGx will share clinical trial data for certain of its opioid products. |
| Exceptions | |
| When Studies are Listed | SpecGx will make additional clinical data available for any new opioid products or new indications for existing opioid products that are approved within 30 days after regulatory approval or 18 months after the study completion, whichever occurs later. SpecGx will update the list of studies available when this occurs. |
| Additional Conditions for Access | A Data Use Agreement (DUA) with the research team must be executed prior to the researcher(s) being able to access data within the Vivli platform. |
| What information will be provided | We provide access to anonymized, patient-level and study-level clinical trial data and other information (such as protocols, clinical study reports, and statistical analysis plans). |
| Questions or enquiries | Please contact support@vivli.org |
| Review Criteria for Data Requests | Access to data will be granted to any qualified researcher with a bona fide scientific research proposal. |
| Data Request Review Process | Proposals that have been received via Vivli will be reviewed for scientific merit by the Independent Review Panel members according to their charter. |
| Access to study documents without participant-level data | Access to Clinical Protocol and Clinical Study Reports may be provided without participant level data, upon approval of the research proposal and execution of the Data Use Agreement. |
| Anonymization Standards | Prior to sharing, clinical trial data is anonymized in accordance with applicable laws and regulations. |
| Clinical Study Register or Website | www.mallinckrodt.com |