We are committed to our clients’ success and manage processes up front so that final data can be delivered shortly after database lock. Our data management services are backed by deep experience in providing a full range of services, across a variety of therapeutic areas and among many technologies — including electronic data capture, diaries and submissions. All services can be provided as part of a full-service solution or on a stand-alone basis.

Our comprehensive services include:

  • Case Report Form (CRF) design, electronic review and tracking
  • CRF completion guidelines
  • Database design and Trial Design Specification
  • Electronic Data Capture (EDC) systems
  • Database validation maintaining 21 Part 11 Requirements
  • Data Management Plans
  • Data Validation Plans
  • Clinical coding with industry standards
  • Double and Single data entry for paper and EDC systems
  • Edit check development and programming
  • Data validation and query resolution
  • Electronic lab data transfers and review
  • Datasets compliant with Clinical Data Interchange Standards Consortium (CDISC).  Including Study Data Tabulation Model
  • (SDTM) datasets, define.xml, Clinical Study Data Reviewer’s Guide
  • Analysis-ready data sets creation through SAS, XML and other formats
  • Electronic submission-ready data sets production
  • Project data management
  • Status reporting

IRB

Novum’s Independent IRB is responsible for the initial and continuing review of Early Phase studies conducted at Novum sites, and also serves as a central IRB for all Clinical Trials managed at investigator sites by our Clinical Trial Management division. Established in 1992, the Novum Independent Institutional Review Board (NIIRB) is composed of professionals with varied backgrounds and a wide range of interests whose primary responsibility is to ensure that appropriate steps are taken to protect the rights and welfare of human subjects participating in research studies. For studies with special requirements, the Novum Independent IRB has access to advisory experts who can provide scientific and medical expertise via a large network of specialists.

Compliance – The NIIRB operates in compliance with guidelines provided by the Food and Drug Administration (FDA Parts 50 – “Protection of Human Subjects,” 56 – “Institutional Review Boards” and 812 – “Investigational Device Exemptions”), by The Declaration of Helsinki-the comerstone document on human research ethics.

Quality Assurance

Quality and integrity form the core of every Novum study. The Quality Assurance Team is independent of the Novum operational units and reports directly to the CEO. Quality Assurance is responsible for maintaining the integrity of Novum’s scientific processes and overall business operations.

Quality Assurance teams conduct a combination of audit plans, visits and reports for all Early Phase studies and Clinical Trials. These experienced specialists audit all aspects of a study, from study initiation through compilation of the CDISC compliant report.

Within our Early Phase Clinics, QA audits are conducted on clinical studies. These include a QA audit of specific aspects of the study (e.g., dose administration, blood sample collection and processing) to ensure compliance with the study protocol and Novum SOPs. Within Clinical Trials, QA audits both our internal processes and the clinical sites that are conducting the study. These audits ensure that the sites are ready for potential FDA inspections and that all of Novum’s monitoring and study management SOPs are followed. In addition, the QA Team reviews the compiled study report to ensure completeness and accuracy. QA generated audit reports are submitted for management review to ensure continuous quality improvement.

By adhering to the highest quality assurance standards in our internal processes, at each Novum clinical site and throughout our network of investigator sites, we ensure the regulatory readiness of all studies.

Medical Affairs

Medical Affairs, driven by medical acumen and a commitment to patient safety, provides a comprehensive package of medical services to support each study. Our physicians, who are board certified in various capacities, provide cross-functional solutions, including medical guidance in the areas of protocol design, endpoint selection and inclusion/exclusion criteria; adverse event coding; and coordination of operational activities.

In addition, each pursues new and innovative solutions in his or her area of expertise to continually enhance Novum’s service offerings.

Pharmacy

Pharmacy services are performed by Pharmacists and technicians who are experienced in study research methods and requirements, including retention samples. All Novum pharmacies handle dose preparation and sterile preparation of intravenous dosages and are registered with the DEA. The Pittsburgh pharmacy serves as a central distribution point for the large multi-center clinical endpoint studies managed by the Novum Clinical Trial Management team.

All pharmacies feature:

  • Temperature monitoring
  • Limited access
  • Backup generators
  • Double lock and key, fingerprint security
  • Controlled Substance Registration Certificate