Drug development companies, especially those operating outside Big Pharma, frequently face complex and often daunting tasks when obtaining and organizing data for regulatory submission.

Clients often grapple with these requirements in the evolving drug development landscape, especially concerning Good Laboratory Practice (GLP) and non-GLP studies. GLP studies adhere to stringent protocols, ensuring data integrity and reliability, while non-GLP studies may offer valuable insights earlier in the development process.

Helping current and future clients understand and simplify regulatory requirements is one area where the in-house expertise at Attentive Science shines. Our experienced team is highly skilled in navigating the intricacies of the Standard for Exchange of Nonclinical Data (SEND) for GLP and non-GLP drug development projects and what will be required by the regulatory authorities.

Understanding SEND Services in Drug Development

SEND is a standard format developed by the Clinical Data Interchange Standards Consortium (CDISC) for submitting nonclinical data to the U.S. Food and Drug Administration (FDA) in drug development projects, to facilitate regulatory review and analysis, and enhancing data quality as well as comparability across studies.

The GLP Difference: A Brief Explainer

GLP (Good Laboratory Practice) and non-GLP drug development projects differ primarily in the standards and regulations governing the conduct of nonclinical studies.

GLP Drug Development Projects:

● GLP refers to a set of principles and guidelines for the conduct of nonclinical laboratory studies, ensuring the quality, integrity, and reliability of the data generated.

● Studies conducted under GLP compliance adhere to strict protocols regarding study conduct, documentation, personnel qualifications, facilities, equipment, and quality assurance oversight.

● GLP-compliant studies are often required for regulatory submissions to demonstrate safety and efficacy.

● Regulatory agencies such as the U.S. FDA and the OECD (Organization for Economic Co-operation and Development) mandate GLP standards.

Non-GLP Drug Development Projects:

● Non-GLP projects usually encompass nonclinical studies conducted without Quality Assurance oversight. This is because these types of studies are exploratory in nature and rapid decisions need to be made to obtain the required information.

● These studies provide valuable data during drug development, especially during early discovery and research phases, to establish dose selection for the definitive regulatory studies conducted in compliance with GLP.

● Non-GLP studies might be exploratory or preliminary. For example, academic or research facilities typically conduct these studies prior to conducting studies for formal regulatory submission.

When scoping out projects with any contract research organization (CRO), it’s essential to understand that the main difference lies in the adherence to GLP standards, which ensure the quality and reliability of data generated in nonclinical studies for regulatory purposes, and what will be required as part of the submission package. Hammering out specific requirements ahead of time carries with it the potential to save drug development projects precious time and money and, in particular, what the SEND requirements are, for a specific package with regards to the addition of GLP/non-GLP data and reports.

Tailored Solutions for GLP and Non-GLP Projects

Larger CROs will often shoehorn smaller drug development companies into a one-size-fits-all production timeline that may or may not be ideal for the project at hand. 

Attentive Science recognizes the diverse needs of our clients, whether they require GLP-compliant studies for regulatory submissions or seek insights from non-GLP research.

Our team is uniquely structured to offer a "boutique" approach to CRO services, providing personalized attention and tailored solutions to meet each client's specific requirements.

Proactive Scoping for Future Needs

One of the hallmarks of the Attentive approach is our commitment to saving our clients unexpected hassle and additional costs by thoroughly scoping out future needs before work begins.

Drug development projects evolve, and regulatory requirements may change over time. Therefore, we engage with clients upfront to identify potential future needs, such as converting non-GLP studies to SEND-compliant formats where applicable.

By proactively addressing future requirements, we ensure that clients understand the regulatory landscape and can plan accordingly, minimizing disruptions and delays in the submission process.

Expertise and Attention to Detail

With years of experience in drug development and regulatory compliance, our team at Attentive Science possesses the expertise and attention-to-detail necessary to navigate the complexities of SEND standards.

We understand that every project is unique, and we pride ourselves on anticipating our client's needs by offering tailored solutions and proactive guidance at every step.

‘GLP…or Non-GLP?’ Ask the Experts at Attentive Science

If you're navigating the intricacies of SEND data standards for your drug development projects, look no further than Attentive Science.

Whether you're embarking on GLP studies or exploring non-GLP research avenues, we provide the expertise, support, and personalized attention you need to succeed.

Contact Attentive Science today to learn how we can help you in your mission to develop cures and remedies, and streamline your drug development journey. Let us be your trusted partner in achieving regulatory success.