Sonas Consulting has been providing premier EDC and e-Clinical consulting services within the clinical trial industry for more than a decade. Our founder, Jeff Sonas, was the chief architect and principal engineer behind the creation of Ninaza, an electronic data capture (EDC) product allowing rapid and efficient implementations of EDC solutions for many different studies.
We have consulted for pharmaceutical sponsors, CRO’s, and technology vendors across a wide range of projects large and small.
Extended Case Study of a long-term consulting engagement with a top-ten pharmaceutical sponsor:
EDC Process Development
As part of a five-year project to improve the efficiency, standards adherence, and regulatory compliance of EDC clinical trial development within the Clinical Data Management group of a top-ten pharmaceutical sponsor, we designed the processes and authored the Standard Operating Procedures for all new EDC study builds, EDC study amendments, and EDC Global Library volumes.
Along with writing the applicable SOP’s, we created all the document templates and utilities to support sponsor data managers in their specification of study-specific User Requirements based on corporate and TA-specific Global Library standards. Data Managers used the utilities to check their User Requirements for errors, inconsistencies, or omissions, leading to higher-quality deliverables to their EDC programmers and fewer back-and-forth rounds of User Requirement finalization. Other utilities allowed Data Managers to automatically create testing checklists for study-specific EDC elements, greatly increasing SOP compliance thanks to the direct link between the utilities and the validation documentation formats.
Targeted Study Document Checking/Review
The sponsor has a wide range of expertise and institutional knowledge among its data managers and EDC programmers. In order to leverage this expertise across a large number of study builds, we developed a utility to run a sophisticated scan of EDC study user requirements and study build metadata files. This scan performed thousands of automated checks among the study-specific documents (user requirements and programmed study metadata) and corporate standard documents, including adherence checks and verifying correspondence between the requirements and the programming. This saved dozens of hours per study of tedious/repetitive verification, as well as enabling efficient peer review by experts who could focus mainly on the output of the issues flagged for review by the automatic checker.
EDC Development and Global Library Enforcement
We designed and programmed the validated EDGE Utility (EDC Development and Global library Enforcement) as a custom application for the sponsor, supporting data managers and EDC programmers in following the controlled process for specifying, building, reviewing, and testing their EDC study builds and Global Library volumes. During the first year this utility was used for all EDC study development at the sponsor, the average study build duration (the time from starting study-specific User Requirements until the production release) was reduced by two full weeks per study, a 20% improvement that sponsor management attributed directly to the increased efficiency gained from using the EDGE utility. Click here for a summary of EDGE functionality or here for a more detailed review.
EDC Database SQL/Data Mining
The sponsor’s preferred EDC vendor provides back-end SQL Server access to its clients. Having the most database expertise within the sponsor team, we developed a number of sophisticated queries to compare any two study metadata versions in order to report on levels of global library adherence as well as the magnitude of study amendment migrations. We also wrote queries to identify “dormant” EDC users who had ceased active use of the system and were candidates for inactivation per SOP requirements, and developed functions to calculate a number of Key Performance Indicators (KPI’s) to measure site and clinical team performance at multiple departmental levels.
Validation Engineering
The sponsor’s corporate procedure for software validation requires extensive specification of user requirements and functional requirements (U/FRS), along with the creation of large qualification protocols for Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ). Because multiple software utilities that we developed for the sponsor were required to follow this validation procedure, we authored the U/FRS and IQ/OQ/PQ for those utilities, along with developing the utilities themselves and producing the files used during the execution of the qualification protocols. The protocols were singled out by regulatory compliance representatives for the high quality of the writing, and every validation was highly successful, with fewer than five deviations in each validation.
Requirements and Specifications
— Core Product Requirements Engineering
— Study Implementation Requirements Engineering
— EDC/eClinical Study Implementation Design
Sponsor Outsourcing Support
— Sponsor Support for Software Validation
— Risk Mitigation and Contingency Planning
— Vendor Evaluation
— Study Rescue
— Vendor Auditing
Database Expertise
— Product Design and Development
— Database Validation and Testing
— Data Migration Support[/inline]
Case Studies
++ REQUIREMENTS AND SPECIFICATIONS
— Core Product Requirements Engineering
An EDC/eClinical vendor wanted to introduce new features to its core product and also perform a full validation of existing core product functionality, which required extensive documentation of existing product features. Sonas Consulting designed a product requirements document and numbering scheme that adhered to the vendor’s internal requirements standards while still being tailored to the particular features of the software, and created detailed requirement listings both for existing core functionality as well as the new features being added to that core. This allowed the vendor to perform a complete validation (for the first time) of their core product.
— Study Implementation Requirements Engineering
An EDC/eClinical vendor wanted to standardize and improve its requirements document format used to define the study-specific specifications for study implementations. The vendor engaged Sonas Consulting to work with existing clients to define their study-specific needs and to document those in an optimal format. Having done this for a few studies in consultation with the vendor, Sonas Consulting then proceeded to design and develop the new requirements document format, to use it for defining the study implementation needs for all upcoming studies, and to train vendor personnel on the details of the requirements format and best practice for specification design by vendor personnel.
— EDC/eClinical Study Implementation Design
A sponsor was working with a particular EDC/eClinical vendor for the first time, and requested Sonas Consulting to help with an assessment of vendor capabilities applicable to the sponsor’s own business practices and study domains. Sonas Consulting collaborated with sponsor and vendor personnel to design and define proper configuration/customization of the system that would harmonize with vendor capabilities and sponsor requirements.
++ SPONSOR OUTSOURCING SUPPORT
— Sponsor Support for Software Validation
Sonas Consulting authored complete system documentation for a large sponsor’s system requirements for a major EDC vendor’s core product, as well as designing, documenting, and executing a formal User Acceptance Plan on behalf of the sponsor to test that EDC vendor’s core product. As a follow-up, Sonas Consulting also authored complete system documentation for several studies utilizing that EDC vendor’s core product, as well as designing, documenting and executing a formal User Acceptance Plan to test the system functions of each of those studies.
— Risk Mitigation and Contingency Planning
A sponsor wanted to evaluate and mitigate its business risks associated with the use of a particular EDC/eClinical vendor, so they engaged Sonas Consulting to perform risk assessment and subsequent mitigation of that risk. This ultimately included setting up new vendor relationships between the sponsor and other vendors to perform services such as data center hosting and software escrow management, as well as significant changes to the hardware architecture and ownership structure, a process that was planned and managed by Sonas Consulting.
— Vendor Evaluation
Sonas Consulting worked with a large sponsor to reassess their outsourcing strategy with regard to EDC/eClinical vendors, to perform evaluations of the capabilities and benefits/drawbacks of those vendors, and thereby make recommendations of changes to the sponsor’s outsourcing strategy.
— Study Rescue
A large sponsor had multiple ongoing studies being rescued from a failed EDC/eClinical vendor over to a different vendor. This study rescue process included evaluating the requirements format used by the incoming vendor for defining the study requirements as well as data migration requirements, reverse-engineering detailed study specifications for the relevant studies supported by the failed vendor, and collaborating with the sponsor and vendor to translate the study design and specifications from the previous vendor’s system into an appropriate EDC/eClinical implementation under the incoming vendor.
— Vendor Auditing
A CRO was using a particular EDC/eClinical vendor to provide technology solutions for one of its studies for a particular sponsor. The sponsor was going to audit the CRO and wanted assurances about the technical vendor. So the CRO engaged Sonas Consulting to perform a two-day on-site audit of all the vendor’s procedures, policies, and documentation that were relevant to the CRO’s usage (including Tech Transfer) of the technical vendor’s software.
++ DATABASE EXPERTISE
— Product Design and Development
An EDC/eClinical vendor wished to add functionality to its existing software product and easily implement the new features on both existing study implementations already in production as well as newly developed implementations. The vendor engaged Sonas Consulting to evaluate its existing software product and to design and develop a metadata-based architecture where study-specific details were abstracted into a metadata storage format, in conjunction with the creation of reusable software modules that would require minimal modifications when implemented on different studies. Sonas Consulting designed, documented, and developed all changes to the existing software and any new or existing processes affected by these new product features.
— Database Validation and Testing
An EDC/eClinical vendor wanted to expand the scope of its study testing and validation to include a much larger test dataset, one that includes all possible equivalence partitions of input data. This involved the development of a toolset and process for generating test data automatically (through the execution of appropriate study-implementation procedures) as well as subsequent verification of that test data to ensure it was created in accordance with study requirements.
— Data Migration Support
Sonas Consulting worked with a top-5 CRO (Contract Research Organization) to design, document, and implement a data migration for a study with multiple sponsors, including a majority of the 15 largest pharmaceutical companies in the world. The study data included millions of data records across more than 10,000 patients, and needed to be migrated and transformed into the proprietary database structure of a particular EDC vendor that was converting the study to EDC. Sonas Consulting wrote all the supporting documentation and also wrote all of the custom database scripts to perform the migration.