Over the years our team has helped numerous Start-Ups and we have real success stories - gene therapy and other rare disease companies that have benefited from our high quality work and successfully filed their products. 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 rare disease client preparing for an NDA, we conducted an Inspection Readiness Gap Assessment. The outcome from the Gap Analysis included gaps in SOPs, Training and Vendor Activities. As part of a program of “gap closure activities” we drafted SOPs in Clinical, Regulatory, Manufacturing as well as General SOPs and we conducted an assessment of the client’s TMF.
As a result of our work, the client had a successful inspection and got it’s product approved, the first of a kind treatment for a rare condition. In review of the SOPs, the Inspector commented on the high quality of the SOPs in place.
For a Start-Up client, DArcy Consulting drafted multiple SOPs covering GCP, GMP and Quality.
Our client was about to start a Phase II pivotal program and realized that it 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, it realized that these were legacy SOPs acquired when the asset was transferred. Hence they 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 II 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 covering clinical, manufacturing and quality. In addition, DArcy rolled out training for the SOPs across the organization. As a result of our work, our client was comfortable proceeding with its phase II study know that it had a set of high quality SOPs in place which were aligned to regulatory requirements as well as to the company’s working practices.
Our client, a rapidly growing Start-Up biotech company recognized that while individuals across the company were compliant to their training requirements, there was no organizational framework or structure for managing training records. As a result, hundreds of training certificates were being captured on a general sharefile. The client needed an organization framework to support the training SOP and ensure training records were appropriately captured and allocated to individual training records.
Based upon the training SOP, which DArcy drafted, DArcy helped our client develop a training curricula forits employees. DArcy proceeded to drive the training requirements (RUS training), compile records and update training folders. DArcy also conduct GCP Training and GMP Training for the company.
As a result of our ongoing engagement, our client has fully compliant training records for all its staff.
For a number of rapidly growing biotech companies, planning for clinical trials, DArcy has completed a number of vendor audits covering both GMP and GCP vendors.
For one particular client, our client had already engaged with a number of GMP vendors, all reputable vendors in their fields however with no audits in place, it needed to quickly confirm and establish the evidence that the vendors were suitably qualified to conduct the work. In addition, our client was interested to understand areas they should focus on from an oversight perspective. Conducting the GMP audits was critical therefore to ensure vendors were compliant to the agreements in place, particularly Quality Technical Agreements. DArcy conducted numerous GMP audits and used the outputs from the audits to update the Quality Technical Agreements as well as update vendor oversight requirements.
For many early stage Companies, DArcy has been instrumental in assisting in the establishment of basic Quality Infrastructure. Services around Quality Infrastructure include educating on the Importance of Quality, the impact of Poor Quality (or lack of Quality) and establishing components of Quality (which vary based upon the company’s size and maturity).
A Research Institute conducting research and licensing candidates to Pharma/Biotech companies approached DArcy for some assistance in conducting a Quality Gap assessment and addressing gaps from the assessment. The Institute wanted to ensure that when licensing candidates to larger 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 Rare Disease 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 qualitatively and quantitively to assess each vendor offering and hence identify the right system to support its needs.
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 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 a exceedingly rare disease.