Over the years our team has helped numerous Start-Ups and we have real success stories - gene therapy and rare disease Start-Ups that have benefited from our high quality work and successfully filed. While our approach varies, our clients enjoy similar experiences – measurable success. To see what we have done for other companies, please review the list of client projects below.
For a client preparing to file an NDA for a gene therapy to treat a rare disease, we conducted an Inspection Readiness Gap Assessment. The outcome from the Assessment included gaps in SOPs, Training and Vendor Activities. As part of a program of “gap closure activities”, we:
- Drafted general, clinical and regulatory SOPs
- Conducted an assessment of the client’s TMF
Subsequently, the client had a successful inspection and its product was approved, the first of a kind treatment for a rare condition. Anecdotally, we were told that the Inspector commented on the high quality of the SOPs in place.
For a Start-Up client, DArcy Compliance Consulting drafted multiple SOPs covering GCP, GMP and Quality.
Our client was about to start a Phase 2 pivotal program and realized that they needed a suite of SOPs to cover all aspects of its development work, ranging from vendor interactions to clinical trial activities and manufacturing oversight. Our client also recognized the efficiencies to be gained from having simple instructions in place to drive consistency across the organization in how everyone did the work. While the client already had a library of SOPs in place, they realized that these legacy SOPs were no longer relevant since they did not reflect how the work was done. A new set of SOPs had to be drafted before the Company could start its Phase 2 work.
In addition to SOP development, our client also needed to ensure everyone was trained on the SOPs and had the necessary records in their training folders.
Over a three month period, DArcy developed over 25 SOPs and rolled out training on the SOPs across the organization. As a result of our work, our client was comfortable proceeding with its Phase 2 study knowing they had a high quality set of SOPs which were aligned to regulatory requirements and to the company’s working practices.
Our client, a gene therapy client, was growing quickly and recognized that while individuals across the company were compliant to their training requirements (Pre Clinical and Clinical training) there was no organizational framework or structure for managing training records. Hundreds of training certificates had been sent to the head of Research and filed in a general folder.
Based upon the client’s Training SOP, DArcy Compliance Consulting proceeded to develop a Training Curricula for each employee in the organization highlighting what employees need to be trained on what activities and what evidence was required within each employee training folder.
In consultation with Line Managers across the organization and based upon job specification, DArcy developed a tailored training curriculum. DArcy then provided the SOPs to the employees based on the curriculum. In addition DArcy compiled training records and training certifications and populated training folders for each employee.
In addition to SOP training, DArcy also conducted GCP Training and GMP Training for the company. All who attended and then successfully passed the quiz were provided with a Training Certification.
As a result of our ongoing engagement, our client has fully compliant training records for all its staff.
For a rapidly growing biotech company, planning for Phase 1 studies, DArcy completed several audits of GMP and GCP vendors.
The client had already engaged with some reputable GMP vendors; however, with no audits in place, confirmation and evidence that the vendors were suitably qualified to conduct the work was needed. In addition, our client wanted to understand areas of focus from an oversight perspective. Conducting the GMP audits was critical therefore to ensure vendor compliance with the agreements in place, particularly Quality Technical Agreements. DArcy conducted the GMP audits and used the outputs to update the Quality Technical Agreements as well as the vendor oversight requirements.
For a number of Start-Up companies, DArcy conducted GCP audits of their CROs. As a result of these assessments, our clients are better prepared to provide oversight, especially focusing on areas where the audits identified weaknesses or gaps.
A Research Institute conducting research and licensing candidates to Pharma/Biotech companies approached DArcy for some assistance in conducting a Quality Gap assessment Early Stage Programs and addressing gaps from the assessment. The Institute wanted to ensure that when licensing candidates to Pharma, it had the evidence to support the quality of its research/ data (data integrity, traceability etc.). DArcy established a ‘fit for purpose’ Quality infrastructure comprising key elements of Quality including multiple SOPs as well as training on the SOPs. DArcy also established vendor management procedures, templates and tools to assist the Institute in effectively overseeing the work of its multiple vendors (particularly the quality of its research activities). DArcy continues to work with the Institute as it rolls out its QMS across the Organization.
For a Gene Therapy Client, DArcy has been instrumental in assisting them to identify the right Quality Management System to support their needs. Having reviewed multiple vendor QMS packages, DArcy established a user requirements tool, tailored to the client’s specific needs which was ‘scored’ throughout the vendor selection processes. As a result of the various presentations, vendor follow ups, the DArcy-Client team were able to apply scores across a number of parameters for each of the vendor systems. The use of an “Assessment Tool” enabled the client to qualitatively and quantitatively assess each vendor offering and hence identify the right system to support its needs. DArcy is currently supporting our client in implementing it’s QMS.
Deviations Close Out
When one of our former clients required assistance with closing out overdue GxP deviations, they requested support from DArcy Compliance Consulting. DArcy stepped in and worked cross-functionally to complete open investigations, author deviations and, in some cases, perform QA approval of investigations. In addition, DArcy assumed the lead role in a weekly task force meeting to engage key stakeholders with a prioritized plan for remediation and to provide status updates.
For Cause Audit
When our Start-Up client identified a major problem in their clinical operations, the head of Compliance initiated a ‘for cause audit’. The scope of the problem was quite large and covered ongoing clinical trials across Europe, US and Australia. DArcy Compliance Consulting were asked to take on the role of overall Project Manager to oversee the work of the client team as well as multiple vendors who were brought in to address the multitude of audit findings. Because our client was filing its first NDA within a year, time was of the essence to identify and ‘fix’ the issues to ensure they did not reoccur.
DArcy set up the overall Remediation plan, mapped out all the activities to be completed and who was responsible for what. DArcy scheduled and managed the weekly meetings to track the progress of remediation and completion of critical activities. Within 3 months, all outstanding activities from the project plan were closed out and the ongoing activities were ready to be transitioned to the client’s QA group where they were managed internally as ongoing CAPAs. Within 6 months, all remediation activities were completed and the client proceeded with its NDA which was subsequently approved. The first treatment in the market for an exceedingly rare disease.