Amidst the SGS maxim framework for early-phase clinical trials, this maxim emphasizes aligning trials with regulatory standards. Prioritizing compliance ensures credibility, safety, and future approvals. Strategic collaboration with regulators enhances drug development success. Delve into key insights and case studies to navigate regulatory pathways effectively.
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Challenges for smaller biotech firms
In the intricate landscape of drug development, the progression through clinical trials holds paramount significance. Navigating this terrain requires the establishment of robust strategic partnerships with specialized entities, including Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and regulatory consultants. This challenge is particularly pronounced for smaller biotech firms contending with limited resources and the intricacies of pipeline management.
Streamlining the supply chain for expedited innovation
In the pursuit of expeditiously delivering innovative products to patients, especially those requiring accelerated FDA approval, the hurdles can be extremely tough. Overcoming these challenges entails streamlining the supply chain and engaging partners with specific expertise, ranging from CDMOs for formulation and manufacturing, to CROs equipped with Clinical Pharmacology Units for pivotal First-In-Human (FIH) and Proof-of-Concept (POC) studies and bioanalysis labs to develop new methods and to analyse the samples.
Coordinating partnerships and timelines
Coordinating multiple partners, reconciling conflicting timelines, and ensuring effective communication present significant challenges. These hurdles necessitate an agile and resilient approach for a seamless journey from the discovery phase to ommercialization.
To address these intricate needs and challenges, innovative solutions have emerged. Beyond conventional services, biotech and pharmaceutical companies are seeking comprehensive consultancy from the initial contact, leveraging the expertise of formulation, bioanalysis, regulatory and clinical professionals. This integrated approach ensures that companies receive multidisciplinary advice and support throughout the entire development process.
Innovative solutions for comprehensive support
One such innovative model is SGS PACE (Product Accelerated Clinically Enabled). This model provides companies with a single point of contact, a dedicated program manager, and therefore a streamlined communication, offering seamless assistance from early preclinical stages to Proof-of-Concept. The collaboration between client teams and SGS experts results in custom strategies, efficient timelines, and cost-effective solutions tailored to specific needs and budgets.
The value of SGS PACE: Simplifying project coordination
The true value of SGS PACE lies in its ability to simplify complex project coordination. The consultancy service establishes a clear roadmap at the project's onset, outlining strategies for formulation, bioanalysis method development, manufacturing, and clinical development. This comprehensive plan, enriched with different scenarios, estimated timelines, and budgets, empowers clients to make well-informed decisions throughout their drug development journey. By tapping into SGS's considerable expertise, SGS PACE ensures successful project execution without the intricacies of managing multiple partners, providing clients with confidence as they embark on their drug development endeavors.
