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.
A Practical, Staged Approach to Building a Quality Management Program
When it comes to Quality Management in clinical trials, the Regulators are unambiguous in their expectations. They not only expect to see a functional Quality Management System (QMS), but they require documented evidence of quality in all aspects of planning, conduct, and reporting of your clinical trials. In other words, “if it is not written down, it did not happen” or “if it is not written down properly, then it was not done properly.” Failure to meet these industry quality standards can be costly. For Start-ups, where resources are limited, lack of evidence of quality or noncompliance can put the future of an entire submission in jeopardy.
For many Start-ups implementing a quality management system (QMS) can be daunting. It's important to note that when we talk about a QMS, we are not necessarily talking about an electronic system. We are talking about a series of interconnected processes, where the output from one process of the QMS forms the input to another. The processes that make up a basic QMS include but are not limited to Standard Operating Procedures (SOPs), Training and Vendor Audits. There are more of course but these are the first processes to be established and form the foundation of the QMS. For Start-ups a paper based QMS is perfectly acceptable. As the company grows an electronic QMS can facilitate this process.
For Start-ups, when/ how to start to build the QMS can be challenging. Knowing ‘when’ to start is often the first hurdle. As discussed in our recent blog, “Addressing the unique needs of Life Science Start-ups”, we advocate getting the Quality Management processes started as soon as Protocol is being developed.
The next step of ‘how’ is not difficult. Setting up a QMS is done step-by-step with the stage of development and clinical strategy. Developing SOPs is the most foundational step to building quality within the organization. While it seems complicated on the surface, writing SOPs is one of the main activities that DArcy Compliance Consulting (DArcy) does for our Start-up clients.
DArcy helps Start-ups by helping them build their Quality Systems. Here we advocate ‘Phase Appropriate Quality Management’. In other words, do only what is required, and scale according to the progression of your clinical trial. With too many clients, we see over complicated Quality. SOPs which are not required, at the stage in development, which can put an undue burden on the organization. Think of all the training required on SOPs that are not necessary in the first place.
Building a Quality Management System – Case Study
A Start-up Biotech approached DArcy for assistance in establishing a QMS that would support its existing programs. The client wanted to understand risks and compliance gaps inherent in its clinical program that could be proactively addressed ahead of a regulatory agency inspection. Establishing a functional QMS was ultimately the requirement.
The client wanted to create a phase appropriate QMS. Firstly, they wanted to understand where gaps and risks existed across their clinical program and then a plan of action to address gaps. They did not want a ‘best in class’ QMS. They wanted the basics, a functional implementable QMS, that could be scaled as the organization evolved.
What We Did – Gap Analysis
The first step of the program was the completion of a Gap Analysis of the client’s existing clinical/quality infrastructure. This was done by:
- Conducting in-depth interviews with key individuals across the organization to understand the approach to Quality and perception of gaps.
- Assessing existing SOPs and Policies to determine if they were ‘fit for purpose’ and compliant with guidelines.
- Reviewing training records for those individuals involved in the clinical trial to ensure records were appropriately in place.
- Examining key vendors to ensure they were qualified to conduct the work with documentation of oversight in place.
After interviewing over twenty key stakeholders, assessing more than sixty policies and SOPs, and reviewing training records and vendor contracts, DArcy was able to identify gaps in the client’s Clinical Quality. DArcy then conducted a workshop with the client team to present feedback, agree on gaps, and prioritize activities to address gaps.
Working with our client, DArcy remained in place and helped:
- Create SOPs where SOPs gaps existed;
- Create a training curriculum and roll out training across the entire organization (SOP training as well as GCP and GMP Training);
- Establish an Approved Vendor List and conduct vendor audits on critical vendors;
- Establish a ‘paper based’ QMS to support all Quality related activities. Over time, our client did transition to an electronic QMS and DArcy remained to support the implementation of the new system.
A Solid Quality Management System
Upon completion of the engagement, the client now has a robust and enduring QMS. It now has high quality SOPs; all relevant individuals have completed training records in place (including GCP training); and Approved Vendor file is in order showing status of all vendors and associated audits. In addition, there is renewed confidence in the progression of the clinical development and that all quality requirements are not only in place but verified and the client’s team is comfortable in their knowledge of what it need to do to maintain quality.
From DArcy’s perspective, our personal engagement and coaching was a success. Our thorough, organic approach provided the client with specific guidance to meet it objectives and an effective QMS where it can manage the daily activities on its own. Of course, we are always there for our clients when and as needed.
About DArcy Compliance Consulting
DArcy Compliance Consulting was formed to address a very specific need in the life science industry: the need for practical, implementable quality infrastructure for Start-ups. Whether you are looking for SOPs to be developed, training to be rolled out, vendors to be audited, QMS’ to be established, our team of experts are ready to assist. Contact us today to start the conversation.
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.