Navigating Expedited Drug Development Pathways Globally: Q&A with Quotient Sciences Experts

As the demand for faster access to life-saving therapies grows, regulatory agencies around the world have introduced expedited approval pathways to accelerate drug development without compromising safety or efficacy.

Programs like the FDA’s Fast Track and Breakthrough Therapy designations offer sponsors a strategic advantage when developing treatments for serious or rare conditions.

Recently, a new type of designation, the Commissioner's National Priority Voucher (CNPV) program, was announced by the FDA. The CNPV aims to prioritize therapies that meet one of the following criteria:

• Addressing a U.S. health crisis
• Offering innovative cures for U.S. patients
• Meeting U.S. public health needs
• Boosting U.S. domestic drug manufacturing

Compared to current Fast Track, Breakthough Therapy, and similar FDA programs, CNPV vouchers are non-transferable and must be used within two years.1

Quotient Sciences experts address CMC challenges

Navigating these pathways bring CMC challenges requiring regulatory knowledge, technical agility, and a collaborative approach to development to solve.

In this Q&A, Brad Rowe, Senior Director of Integrated Development, and Robert Cornog, Senior Director of Product Development at Quotient Sciences, share insight on how clients can successfully leverage accelerated approval pathways.

From regulatory strategy and clinical manufacturing to risk mitigation and global alignment, they explore the critical elements that drive success in today’s fast-paced drug development landscape and how Quotient Sciences helps clients meet these needs.

What are expedited drug approval pathways and why do they matter?

Brad Rowe: Expedited approval pathways are regulatory mechanisms that allow drug developers to bring therapies to market faster—especially when treating serious or life-threatening conditions. Agencies including the FDA, EMA, PMDA, and others offer programs to support this.

Robert Cornog: These pathways are designed to balance speed with safety and efficacy. In 2024, 75% of novel drugs approved by the FDA used one or more of these designations. That shows how critical they’ve become in modern drug development.

How can pharma/biotech companies determine if their drug qualifies for an accelerated pathway?

Brad: There are several criteria that a company needs to meet to qualify for an expedited status and it varies by region. In the U.S., we often work with clients that have FDA Fast Track or similar. We have seen that between the different regulatory agencies, some qualifying questions are universal, like:

• Does the drug treat a life-threatening condition?
• What’s the global patient population?
• Is it significantly better than current treatments? Or is there an unmet need?

Robert: The principles we apply in the U.S. often translate to these global programs. Also, understanding the age of onset and diagnosis is key. For example, pediatric or geriatric populations may require different formulations. These factors shape early regulatory conversations and development strategies.

Why is choosing the right CDMO critical for accelerated development?

Brad: It has long been our standpoint that a CDMO should be more than a vendor—it should be a strategic partner. That is exactly what we aim to do at Quotient Sciences for our clients. You need a partner who really understands the stakes and is experienced.

Robert: And one who’s flexible, especially when working on a program for a rare disease where batch sizes are small and maintaining the same quality is paramount. Also, a smaller biotech company may also be navigating this process for the first time, possibly looking to license or divest the asset. A good CDMO can help build a roadmap that ensures continuity, even if the asset changes hands.

How does Quotient Sciences help manage compressed timelines and limited resources?

Robert: It’s all about alignment of resources—technical, financial, operational. They must match the program’s phase and risk profile. For example, late-stage development often overlaps with clinical and regulatory work. That means you need to identify and de-risk gaps early. 

In part, that’s why we advocate for integrated development—combining formulation, manufacturing, and clinical dosing, like we do with the Translational Pharmaceutics® platform. It allows for rapid iteration and smarter decision-making.

Brad: I would agree that the challenge isn’t entirely about how to manage the risk, but failing to prepare for it. Our Drug Development Consultants (DDCs) and project managers help our clients navigate decision points, clarify trade-offs, and keep programs on track.

For more insight, download our recent whitepaper and contact us about your next accelerated development program.

References: 1- https://www.pharmaceutical-technology.com/newsletters/fda-creates-new-priority-review-voucher-scheme-to-boost-us-interests

Summary: Kate Darwin, Vice President of Regulatory Affairs at Quotient Sciences, discusses the recovery of MHRA approval times for Phase I trials in the UK. Despite initial delays due to resource shortages, MHRA approval times have improved and consistently meet statutory timelines as of mid-2023. Kate explains the Combined Review process, which streamlines regulatory and ethics reviews into a single application. Quotient Sciences has successfully managed numerous applications under the UK MHRA Combined Review process, ensuring efficient trial approvals and maintaining high standards in clinical research. 

*MHRA timelines and data cited were current as of publication date on January 17, 2025

Why the UK remains a great place to do Phase I research

From discussions with clients over the last 6 months, it’s become clear that there are many misconceptions about UK clinical trial review timelines since the introduction of the Combined Review process. 

In this blog, we speak with Kate Darwin, Vice President of Regulatory Affairs at Quotient Sciences, who dispels the myths and explains why the UK remains a great place to do Phase I research. 

Q: What is Combined Review? 

A: In January 2022, the UK introduced Combined Review (CR), a new process for obtaining regulatory approval for clinical trials. The key feature of CR is that an applicant makes a single application and obtains a single opinion from the MHRA and an independent Research Ethics Committee (REC). It’s a much more streamlined process than having separate applications and approvals. 

Q: What is the application process under Combined Review? What are the timelines?

A: Applicants manage CR applications via an online system called IRAS (short for the Integrated Research Application System), and upload supporting documents in simple PDF format. Regulatory and ethics reviews are done in parallel. If more information is required, a single, joint request for further information (RFI) is raised by the MHRA and REC, the applicant responds, and a single decision is issued. By law, the initial review must be done within 30 days, and the final outcome must be issued within 60 days.

UK Combined Review (CR) takes up to 30 days for the initial review with a final decision issued within a maximum of 60 days from submission.

For trials involving exposure of participants to ionising radiation (e.g. ADME studies), IRAS also generates an application form for Administration of Radioactive Substances Advisory Committee (ARSAC) review. 

Substantial amendments are managed via CR and reviewed within 35 days.

Q: There are rumours that UK timelines for trial approval are very long – is that true?

A: No. A few months after the successful launch of CR in 2022, MHRA review timelines did increase, peaking in Q2 2023. The prolonged approval times weren’t caused by CR, but by a shortage of MHRA resources. 

In summer 2023, the MHRA made clinical trial authorisations its highest priority, redeployed resources, harnessed external resources and improved processes to clear the backlog. 

Since September 2023, the MHRA has consistently met its commitment to meet statutory timelines, and there have been no delays to regulatory approvals for UK clinical trials. 

In summary, UK approval timelines have recovered and have been within statutory limits for well over a year.

Q: What is Quotient Sciences’ experience of UK Phase I clinical trial approval timelines under Combined Review?

A: Quotient Sciences’ regulatory team manage CTA applications for over 80% of the clinical trials in our Nottingham, UK clinic, and make about 25% of annual UK Phase I trial applications. We’ve made over 70 successful submissions under CR, and over 30 ARSAC applications in the last 2 years.

Since the decisive action taken by the MHRA in summer 2023, we’ve submitted over 25 clinical trial applications – all were reviewed within 30 days. 

Our average approval timelines are shorter than both the statutory 60-day limit and timelines achieved by our sponsors, with some of our approval times as short as 36 days. Our highly experienced Regulatory Affairs team of CMC and clinical experts specialises in early phase applications, and our high volume of submissions allow us to quickly understand and adapt to the latest thinking at the MHRA and RECs and advise sponsors on how to avoid RFIs. 

Q: What are current UK timelines for approval of clinical trials and how do they compare internationally?

A: Each month, the MHRA publishes metrics on its performance. The latest metrics show average review timelines (across all clinical trial phases) of 28 days for initial trial applications and 29 days for amendments, with 100% of reviews within statutory timelines.

When comparing UK timelines with other jurisdictions, it’s important to make a fair comparison. For example, the headline FDA timeline for IND review is 30 days; however, unlike UK CTAs, US INDs must be submitted in eCTD published format, which can add 2 weeks to a submission timeline and extend the overall regulatory process. 

We’ve increasingly seen sponsors taking a more conservative approach to addition of protocols to open INDs and requesting start-up timelines of up to 90 days to mitigate against FDA questions. 

UK approval times compare favourably with those in the EU, where CTA approval timelines, assuming no validation queries, are up to 91 days.⁴

Q: What are the advantages of doing Phase I trials in the UK?

A: The UK is one of the top destinations for delivery of high-quality commercial early phase clinical trials², with high scientific, data integrity & ethical standards. We have strong scientific and medical expertise and many highly experienced, MHRA-accredited Phase I units, such as Quotient Sciences’ Nottingham clinic, with a proven track record in delivering internationally accepted trial data, with excellent safety and quality standards overseen by the MHRA. Those units are underpinned by an established Phase I clinical trials infrastructure, including supporting services such as licensed, GMP-compliant manufacturing of high-quality investigational medicinal products, laboratories, monitoring and pharmacovigilance. The attractiveness of the UK business environment is backed up by strong rankings in both the Ease of Doing Business and Global Innovation Index rankings (globally 8th and 4th, respectively)³.

CR provides a straightforward, streamlined application process for clinical trials, with robust regulatory and ethical review, giving sponsors confidence in the quality of their investigational medicinal product, the supporting toxicology, and the scientific integrity and ethics of the trial. Furthermore, the UK’s approachable, respected regulator offers rapid, informal advice and targeted scientific advice. And the UK’s deferral process provides a favourable balance of transparency with commercial protection.

The UK’s robust and pragmatic regulatory environment, coupled with its Phase I infrastructure, enables innovative new medicines to move rapidly from bench to bedside. 

Q: Why place UK Phase I clinical trials at Quotient Sciences?

A: Quotient Sciences have been running Phase I clinical trials at our Nottingham clinic for over 30 years. Aspects that set Quotient Sciences apart from our competitors were recently discussed by our Chief Operating Officer and Nottingham, UK site head, Denise Sutton. 

In summary, we offer sponsors an accredited, GCP-compliant Phase I clinic that meets the MHRA’s stringent safety and quality standards, with a wide range of pharmacodynamic and safety tests, and integrated GMP manufacturing. The clinic is supported by a multi-disciplinary team, including a large medical team with highly experienced Principal Investigators. We have broad experience across a range of study types, including first-in-human single/multiple ascending doses, human ADME studies, drug-drug interaction studies, ethnic bridging and formulation optimization, and employ adaptive, flexible trial designs. Our real-time electronic data capture system generates GCP-compliant data that meets international ethical and data integrity standards, and is accepted by global regulators, including the FDA and EU authorities. And our high-quality regulatory submissions coupled with our experience in participant recruitment, large volunteer database and volunteer-centric approach ensure rapid recruitment and favourable, reliable trial timelines.

Quotient Sciences have collaborated with our regulators to reposition the UK as a robust, reliable and competitive environment for clinical trials. We’re committed to working with sponsors to ensure the fastest route to clinic.

Get more information about Phase I trials at Quotient Sciences

• Read more about our Nottingham, UK site in this recent article from our Chief Operating Officer and Nottingham, UK site head, Denise Sutton

• Browse our Clinical pharmacology services

• Learn about Translational Pharmaceutics programs

References

1. Independent report. Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report. 26 May 2023 (Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report - GOV.UK (www.gov.uk))

2. ABPI. The road to recovery for UK clinical trials, December 2024. The road to recovery for UK industry clinical trials

3. HM Government Life Sciences Vision, 2021 (Life Sciences Vision (publishing.service.gov.uk))

4. EMA. CTIS Evaluation Timelines. CTIS training programme, version 2.1, September 2024.

Summary: In July 2024, the FDA released final guidance on human radiolabeled mass balance (ADME) studies, outlining expectations for study design, including the number of evaluable subjects and criteria for mass balance recovery. This guidance affects drug developers and CROs, necessitating updated compliance strategies. These measures align with FDA requirements and aim to streamline ADME study processes.

The FDA issued its final guidance on the clinical pharmacology considerations for human radiolabeled mass balance studies (ADME, or hADME) in July 2024. 

The draft guidance, published in May 2022, had an immediate impact on the expectations of the study design and conduct of ADME studies, such as the expected number of evaluable subjects, while other parts, such as expectations around the criteria for mass balance recovery and the recognition of the different approaches to metabolite characterization by AMS-enable investigations, were still being evaluated.  

With the finalization of this guidance, drug developers, clinical research organizations (CRO’s), and other outsourcing partners are establishing new compliance strategies for conducting ADME programs in 2024 and beyond. In this article, Dr. Adam Robinson-Miller, Senior Manager, 14C Enabled Drug Development, shares thoughts on the newly approved guidelines' impact for the industry.

What are human ADME studies?  

Conventional ADME and AMS-enabled mass balance (also called microADME) studies are usually straightforward in their design. In these programs, single-dose studies are typically conducted in a small cohort of healthy volunteers to help drug companies generate data to support drug development and registration. 

The goals of an ADME study are to understand of the recovery of the radioactivity administered as the parent drug, identify the routes and rates of elimination, and generate samples of plasma, urine, and feces to allow for metabolite profiling and identification. 

At Quotient Sciences, our ADME studies utilize 14C radiolabeled drug substances.

When is an ADME study typically conducted?

A human mass balance/ADME study is a requirement prior to submitting a New Drug Application (NDA). These studies are typically performed before the end of Phase II, although they may be done sooner depending on the indication or in cases where there is fast track or orphan drug designation which may shorten the overall development timeline.

What is the FDA guidance on mass balance?

The FDA’s guidance has described for the first time the agency's expectations for conducting these studies. Many of the expectations reflect the design and conduct of these studies over many years. There are some differences between the traditional approach to conventional and microADME studies that have been significant and have been translated into the final guidance document. 

Key topics of interest include:

• An increase in the number of evaluable subjects
• Consideration around the target % radioactivity recovered from the radiolabeled dose
• Best practice with respect to pooling and profiling methodology across different study designs
• Guidance around the design of AMS enabled studies

Quotient Sciences have described our approach to address potential changes, from the draft guidance in a poster presented at ISSX Boston 2023 and video.

What is Quotient Sciences’ approach to ADME studies?

Quotient Sciences have evaluated the new guidance to ensure that our ADME programs can remain compliant with the new requirements, including: 

• Recommendation to dosing increase to n=8. This allows us to de-risk the likelihood of completing an ADME with an incomplete data set. There will be situations when we must consider restricting dosing. For example, when administering a higher dose than 1mSv or administering an oncology molecule in healthy volunteers, which may make recruitment challenging. In those scenarios, we would discuss the suitability of dosing n=6 subjects only and strategies to maximize the resultant dataset.
• Discharge criteria greater than 90% and less than 1% on 2 consecutive days. Challenges may be faced when recovery does not reach 90% but remains greater than 1% each day; we might be obligated to continue collecting until 90% is achieved. This could result in extended residency periods for drugs with very long terminal half-life. This risk is mitigated by ensuring appropriate wording to allow flexibility and investigator discretion, with robust discussions with our partners.
• Greater than 80% radioactivity in excreta to be identified. This ensures compliance in our metabolite profiling and identification scope.

How will ADME studies be conducted in the future?

We know that ADME studies are critical to adequately describe the metabolism of their study drug and, therefore, to their program’s success in meeting its milestones to reach the market. These changes underscore the FDA’s commitment to rigorous scientific evaluation, a value that is also core to our mission as a company. 

As the technology is now firmly established, there is also an increased demand for AMS-enabled microADME studies. Both approaches allow the generation of critical data to support new drug registration. Quotient Sciences can adopt either methodology as reflected by the specific needs of the molecule. 

Quotient Sciences can support conducting human mass balance studies that meet the highest regulatory standards. Contact us to discuss your next ADME program. 

What is a 505b2 Drug Product?

The 505(b)(2) drug development pathway has steadily become more appealing to drug developers as development times and FDA approval are both accelerated compared to the 10-15 years for a traditional new chemical entity (NCE).

The FDA defines a 505(b)(2) application as “an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use, including, for example, the Agency’s finding of safety and/or effectiveness for a listed drug or published literature.”¹ 

Drug development companies are therefore able to leverage existing regulatory data on an already approved NCE and supplement the package with new information relevant to their new product, typically with additional CMC and clinical data. 

What are benefits of the 505(b)(2) Drug Development Pathway?

From a patient perspective, the benefits of the 505(b)(2) pathway are multiple; improved formulations can lead to increased compliance and enhanced clinical outcomes, new routes of administration can offer greater convenience, and new therapeutic indications can address unmet clinical needs.  

For an innovator company, this repurposing of existing drugs can help manage the value of an NCE through its life cycle, with the benefit of reduced development time, cost, and risk. For a virtual or small drug delivery company, this approach enables innovative ideas to improve upon marketed products or dosage forms resulting in new products that provide benefits to patients. 

In the high-stakes world of pharmaceutical drug development, reduced time and costs are a very attractive offering, however, 505(b)(2) programs can present some unique development challenges, particularly from a CMC perspective that do require careful consideration. 

Understanding how to quickly identify the best formulation to move forward with, whether it is scalable for commercialization, and what key clinical studies are needed to generate the necessary pharmacokinetic, safety & efficacy data, are all factors that play a role in getting regulatory approval. 

To achieve a successful project outcome, one of the first and most critical steps is selecting the right development partner. Mid-sized to large pharmaceutical companies may be looking for a partner who can become an extension of their existing R&D capabilities. Virtual or small biotechs are likely to be seeking a partner that can provide expertise, resources, and capacity in multiple areas of drug development and specifically has experience in working with 505(b)(2) programs.

Choosing a CDMO for 505(b)(2) Drug Development

Quotient Sciences has significant experience developing 505(b)(2) drug programs, and we help our customers turn their innovative ideas into successful products. With state-of-the-art facilities in the UK and US and a global team of drug product and clinical experts, we have the expertise to develop, characterize, manufacture, and evaluate new drug products from the early stages of drug development to commercial launch.

We also offer our customers the ability to accelerate the development of their 505(b)(2) programs by leveraging Translational Pharmaceutics to integrate formulation development, real-time adaptive manufacturing, and clinical testing. A single project manager leads each program. Drug products can be manufactured, released, and dosed in days or weeks rather than months, thus shortening the time for clinical data. The fast availability of human data not only optimizes the formulation but also multiplies the likelihood of success.

A publication by the Tufts Center for the Study of Drug Development compared timelines from traditional multi-vendor outsourcing used in industry to Translational Pharmaceutics. The study concluded that Translational Pharmaceutics saved at least 12 months of development time, amounting to multi-million dollar financial benefits in the form of reduced R&D costs and earlier revenues from product sales.

For more information on our 505(b)(2) drug development capabilities, contact us.

References

1. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/abbreviated-approval-pathways-drug-product-505b2-or-anda-september-19-2019-issue

2. US FDA, CDER, Draft guidance for industry applications covered by section 505(b)2). https://www.fda.gov/ downloads/Drugs/Guidances/ ucm079345.pdf. Published October 1999.

3. US FDA, CDER. Determining whether to submit an ANDA or a 505(b)2)application. https://www.fda.gov/regulatory-information/search-fdaguidance-documents/determining-whether-submit-anda-or-505b2-application. Published May 2019.

4. Freije, I; Lamouche, S; Tanguay M; Therapeutic Innovation & Regulatory Science, 1-11, 2019 DOI: 10.1177/2168479018811889 tirs.sagepub.com

Data integrity is crucial when developing new medicines to ensure their safety and effectiveness for patients.

Data integrity is central to our operations. Our rigorous quality systems across all our facilities ensure the accuracy and consistency of data collected from our development, manufacturing, and clinical programs. This commitment safeguards volunteer and patient safety and ensures compliance with regulatory requirements.

In this article, learn about data integrity in pharma and clinical trial data integrity from our team.

What is data integrity in drug development?                

Data integrity is the maintenance and assurance of data accuracy and consistency over the lifecycle of a drug product/study. It is a critical aspect of the design, implementation, and usage of any system that stores, processes, or retrieves data.

Data integrity must follow global mandatory requirements for regulated healthcare industries for developing and bringing a new medical product to market. In addition, data integrity must comply with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP), often collectively termed GxP.

Why is data integrity so important in drug development and clinical trials?

Data integrity and clinical trial data integrity is essential because it ensures that the raw data collected is valid, complete, and well-documented.

The goal of data integrity is to ensure that all data—original records, observations, and other documented activity— required to reconstruct the clinical study is available, complete, accurate, and authentic. This is to assure the safety, efficacy, and quality of the trial as well as the product being evaluated.

How does data integrity differ from data security in drug development?

Data integrity and data security are related terms, each playing an important role in the successful achievement of the other.

Data security is the protection of data against unauthorized access or corruption and is necessary to ensure data integrity. It is extremely important, as unauthorized access to sensitive data can lead to the changing of records and data loss.

Data integrity is a desired result of data security, but the term data integrity refers only to the validity and accuracy of data rather than the act of protecting data. 

How is raw data defined and how does it relate directly to data integrity?

Raw data is the original and first documentation of the captured data. It is essential that the integrity of raw data be maintained. The documentation of raw data can be done in different formats: electronic data entered in software and computerized systems, data entered exclusively on paper sources, and hybrid systems which have both paper and electronic data entry.

Data integrity requirements apply to each of these formats.

What does ALCOA stand for and how does that relate to data integrity?

Regulators wanted to make certain that the integrity of data is preserved during the drug development lifecycle and through commercialization, so they established the ALCOA principle (later revised to include the “plus").

ALCOA ++ stands for Attributable, Legible, Contemporaneous, Original, and Accurate:
•    Attributable data collection—including the place of origin and the date of data collection. Any alterations to the data should be noted, and clear identification of the person making the correction should be available.
•    Legible—data should be easily read
•    Contemporaneous—time and date of data collection should correspond accurately with the time and date of data recording.
•    Original—original data should be preserved and maintained. In case of duplications/copies of the original data, the creator of the copy should confirm the authenticity of the copies (True Copy).
•    Accurate—data should be error-free, and in case of any updates or corrections, a clear note/comment should be noted to support such change.

The Plus (+) in ALCOA ++:
•    Complete—data should be complete in nature (no omissions), including any changes that have been made during the life of the data.
•    Consistent—data should be chronologically arranged, with an audit trail available for any updates or changes to the data.
•    Enduring—the manner used to record the data should be one that will last a long time without losing readability.
•    Available—data should be accessible whenever needed, over the life of the data, and after study/protocol completion as per regulatory requirements.
•    Integrity—emphasizes honesty and ethical behavior in data handling, encourages a culture of transparency and accountability.
•    Transparency—all data processes should be open to scrutiny, encourages audit readiness and traceability.

How is ALCOA++ applied to GxP?

GxP is a collection of quality guidelines and regulations established to ensure the safety and efficacy of drug products.  Collectively these define the Good Practices, where “x” may stand for laboratory, clinical, manufacturing, or distribution.

Independent of the environment, all regulatory agencies have a statutory obligation to ensure that the drugs available in their specific country fulfill the necessary requirements for safety, quality, and efficacy. They are responsible for effectively reviewing all documents containing both clinical and non-clinical data before giving permission for the marketing of a new drug to ensure the efficacy, quality, and safety of the drug in humans.

Additionally, regulatory agencies encourage manufacturers, clinical sites, and sponsors to implement effective and robust strategies to ensure that accurate and secure data management systems are in place and routinely monitored by the quality unit.

What types of data integrity violations do regulatory agencies monitor? What are the consequences of data integrity violations?

All regulatory authorities have similar expectations on data integrity and clinical trial data integrity. Some examples of violations that have been reported by the FDA, include:
•    Deletion or manipulation of data
•    Aborted sample analysis without justification
•    Invalidated results without justification
•    Destruction or loss of data
•    Failure to document work contemporaneously
•    Uncontrolled documentation
Consequences of poor data integrity and data security can be severe. They can include harm to the company’s reputation, financial losses, vulnerability to hacking or other cyberattacks, fines, legal action, and risks to patient safety. 

What are the benefits of Good Documentation Practices?

Good Documentation Practices (GDP) are part of data integrity and clinical trial data integrity to help ensure that the recording of raw data meets ALCOA++ principles.
Some benefits of Good Documentation Practices include:
•    The creation of legal evidence
•    The determination of responsibility
•    The conservation of acquired skills
•    The facilitation of communication and the ability to provide a story of the events
•    The establishment of an audit trail for clear visibility
•    The accurate reconstruction of events
An inspector or auditor must be able to reconstruct the series of a product’s or project’s events and confirm the integrity of the related data using paper or electronic documents.

What are audit trails and why are they important?

Per FDA, audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record.  Audit trails include those that track the creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).

Audit trails are important because they provide a means of verifying the data's accuracy and completeness by, providing a chronological sequence of events via a clear view of the documentation and record updates to confirm data integrity.  

Ultimately, in any regulatory environment, audit trails are crucial to show record compliance and data integrity. If a task or event is not documented, it does not happen.

In a pharmaceutical manufacturing or clinical setting, data integrity is everyone's responsibility. Best practice is to document tasks immediately and follow established procedures or protocols to avoid risks of miscommunication, assumptions, or worse: the appearance of fraud. It only takes a few seconds to review work to ensure the document complies with ALCOA ++ and maintains data integrity. 

Summary: Michael Astle, Vice President of Legal Affairs at Quotient Sciences, outlines how the company’s legal team streamlines drug development partnerships by eliminating unnecessary delays. Quotient Sciences' in-house legal team emphasizes responsiveness, clarity, and collaboration, helping clients navigate regulatory complexities while protecting all parties. 

The legal function plays a major role in the drug development process, especially when it comes to partnering with an outsourcing provider.

Legal documentation is commonly put in place between sponsor companies and outsourcing vendors to protect all parties who are entering into an agreement, to ensure that deliverables are achieved. From confidentiality agreements (CDAs) to master service agreements (MSA), these important documents, among others, are necessary to kick off project discussions and to agree on the scope of work that will be conducted on a program. The process of putting documentation in place is standard to any drug development program, however, each company can have its own approach which can make the process lengthy and cumbersome.

At Quotient Sciences, we have our own unique philosophy when it comes to the legal aspects of working with our customers and their programs. Our in-house legal team supports our colleagues and our customers by being helpful, responsive, and jargon-free. They understand that the overall goal is to develop products and deliver clinical trials in a safe and timely manner, so they do their very best to truly support Quotient Sciences' mission of molecule to cure, fast.

Streamlining the project kick-off

Having alignment with the customer is key when trying to start a development program.  By taking a modular contracting approach, we ensure that our legal processes are fully aligned with the customer’s own journey for their molecule.  This allows customers to do business based on the stage of development or services that they need at that time.

For example, if a customer needs formulation development and clinical manufacturing support but may not be ready to begin clinical testing for their program, they can contract specifically for the services they need, then add a simple short module to the agreement later.  This enables them to sign their clinical program when they are ready to do so, without lengthy or repetitive legal negotiations. Conversely, if the initial contract is for a clinical pharmacology study but later on the project develops a need for manufacturing support or evolves into an integrated Translational Pharmaceutics® program, it is a simple step to add on a short module to the existing agreement to facilitate this.

Protecting customers & the organization

At Quotient Sciences, our legal team helps protect all parties by having a clear delineation of risks and responsibilities, adherence to regulatory guidance, and a willingness to help customers from other countries navigate local complexities, such as UK or EU privacy rules. This collaborative approach helps protect our customers, our study volunteers, and our organization. 

Benefits of close collaboration

In a business where time and speed are critical, every function, including legal, is focused on how they can streamline processes to get new medicines to patients faster. As their objective, our legal team works in close collaboration with our customers and is responsive to their needs. They are focused on removing the red tape and achieving our mutual goals of signing and starting projects in a safe and timely manner.

They deliver on this in three ways:

• Speed of response: we aim to review all project agreements in 1 week – allowing our customers to progress their projects quickly. No disappearing into a legal black hole here.
• Ease of understanding: our contract templates are designed to be easier to use and understand than most legal documents – for example in our last major update, compared to the prior version of our core template we removed 52% of paragraphs, 31% of the word count and made a 40% improvement on ease of reading on the Flesch scale
• Helpfulness of colleagues: our contract edits are intended to help reach a resolution – we provide comments with context and solutions where possible, not just endless rejections without any rationale. We’re also always happy to talk – no hiding in the background or endless emails, we’d rather pick up the phone to address any challenging topics.

Our legal approach is just one of the many ways that Quotient Sciences is focused on streamlining and accelerating the drug development process for our customers. Contact us to learn more about how we can help accelerate your program to its next milestone.