Nonclinical testing is often the first step in demonstrating the potential safety and efficacy of a healthcare product. A smartly designed nonclinical testing program will support the conduct of clinical trials while allowing flexibility for refinement throughout product development. SciLucent has extensive experience in efficiently devising and executing integrated nonclinical development strategies for drugs, biologics, devices, and combination products for multiple therapeutic indications and routes of administration. We take pride in supporting complex, unique and often unconventional programs and approaches to support our clients’ needs in this rapidly evolving environment. Our integrated services include product development planning, gap analysis and due diligence, program strategy and optimization, expert safety assessments, and program management.
The nonclinical testing program must be designed to meet current regulatory expectations and robust scientific standards, while achieving a balance between efficient use of resources and corporate goals. We can quickly identify sources of potential setbacks, and take proactive steps to avoid delays and ensure that studies are executed as planned. We have unparalleled and specific expertise at ensuring a smooth transition from the planning phase to the execution phase of a nonclinical program. SciLucent has been involved in thousands of different nonclinical studies in all industry-recognized species, allowing us to provide realistic, first-hand, detailed support for study outsourcing, execution, and reporting. We nurture positive working relationships with CROs and enable efficient study management. Our integrated services include program management, study outsourcing support, study monitoring, and study report review and finalization.
Through our extensive experience and exposure to a wide variety of products, review divisions, and regulatory bodies, we can provide expert, customized support for a wide range of therapeutics including small molecules, biologics and specialized therapies including vaccines, monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), gene therapy products, oligonucleotides, combination products, and various medical devices. Over the years, we have accumulated and refined our expertise in challenging scientific and regulatory situations including emerging safety signals (e.g., unexpected toxicities, positive carcinogenicity signals, embryofetal toxicants, clinical relevance assessments) and regulatory issues (e.g., inquiries, clinical hold, refusal to file). Our services include regulatory due diligence and integrated development strategies, authoring and review of nonclinical submission packages, and interactions with regulatory agencies.