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Alfasigma

About Our mission is to provide better health and a better quality of life for patients, caregivers, and healthcare providers. Serving patients is our inspiration and we are passionate about improving their lives.
At Alfasigma, we believe that transparency of clinical study data promotes strong scientific research and advances science and medicine. Alfasigma commits to ensure full compliance with all applicable laws and regulatory guidance and provides specific attention to the protection of personal data at study participant level.
How we share on the Vivli Platform Available studies are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data request form to request company’s data package(s). If approved, requesters will need to sign a Data Use Agreement and the anonymized data will be shared in the Vivli secure research environment.
Studies Listed for Sharing We will provide access to anonymized, patient-level and study-level clinical trial data and other information (such as protocols and clinical study reports) from in-scope Phase 1-4 clinical studies for medicinal products that have received an initial marketing authorization, on approved indications or on indications where the drug development program was terminated.
Exceptions The request may be denied, including but not limited to the following reasons:

  • The requested data is subject to legal or contractual provisions which prohibit data transfer to a third party.
  • Data will not be provided to Requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes.
  • The data request analysis overlaps or interferes with existing or previous AL analyses/publication plans.
  • Requested data is unavailable.
  • The informed consent templates used in the study restrict the sharing of data, or the patient has denied consent to share data with third parties.
  • The request has the potential to produce information that will enable identification of individual study participants: data anonymization is difficult due to e.g. a rare-disease therapeutic area or small sample size.
  • If the request includes source data e.g. images (e.g. x-rays), genetic data and/or exploratory biomarker data.
When Studies are Listed Studies are considered to be available if all the following conditions are met:

  • Study is completed as per protocol.
  • Summary results have been published on ClinicalTrials.gov (CT.gov) and/or the European Union Clinical Trials Register (EU-CTR).
  • Primary manuscript disclosing study’s primary endpoints, key secondary endpoints, and safety data is published.
  • After the first European Medicines Agency (EMA) and/or US Food and Drug Administration (FDA) approval – not applicable if development program was terminated.
Additional Conditions for Access Vivli will forward and approve the request if the following applies:

  • The research team is required to sign a Data Use Agreement.
  • The research team must be appropriately qualified and include at least one Biostatistician.
  • The applicant has certified that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith.
  • The applicant is willing to declare all professional interests, affiliations, possible conflicts of interest, and all sources of support for the research as part of the dissemination of their results.
  • There is a clear scientific publication/disclosure planning.
  • Research team seeking any public disclosure will provide a copy to Alfasigma of any manuscript 30 days prior to submission, for Alfasigma review.
  • The research question must be clearly defined and needs to have relevance to medical science or patient care.
What information will be provided The following documents will be provided to the Researcher:

  • Study Protocol
  • Study data package documentation including information on the dataset structure and data dictionaries
  • Statistical Analysis Plan
  • Anonymized/redacted Clinical Study Report (CSR)
  • Anonymized IPD dataset

Optional:

  • Anonymization Guidance
  • Analytic code
  • Analysis ready IPD data set
  • Case report forms
Questions or enquiries Questions can be sent to Alfasigma by means of the Vivli Enquiry process.
Data Request Review Process Consistently with expectations of good scientific practice, researchers can request access to our studies by providing a research proposal with a commitment to publish their findings. The research proposal is reviewed by an independent review panel. This is a team of external independent experts.
Anonymization Standards   Risk-based approach (both qualitative and quantitative) to minimise risk of patient re-identification, derived from the industry best practices from PhUSE, TransCelerate, and Regulatory Guidance from EMA and FDA. The overall aim is for a pragmatic balance, ensuring an acceptably low risk of re-identification whilst retaining data utility.
Clinical Study Register or Website https://www.alfasigma.com/
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