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Early-stage clinical development solutions
Guiding your early-stage clinical development with precision and care
We ensure robust studies that build a solid foundation for your therapy’s future success, while seamlessly integrating market access, patient, and regulatory aspects.
Navigate hurdles with ease thanks to our scientific, medical, and regulatory expertise
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Strong background in the scientific, medical, and technical aspects of product development, including clinical trial design and execution
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Deep understanding of regulatory requirements and successful interactions with regulatory agencies including the FDA and EMA
Streamlined trials: Agile management, clear communication and cost efficiency
Experience agile project management, smooth and proactive communication, and cost efficiency all in one package—ensuring your early-stage clinical trials are streamlined, effective, and budget-friendly.
FAQs
Is a pediatric development plan necessary at early-stage clinical development?
Yes, a pediatric development plan is essential in the early clinical stages of drug development, especially if there is a possibility that the treatment could benefit children. Regulatory agencies like the FDA and EMA often require companies to consider pediatric populations as early as possible.
Developing a pediatric plan early has several advantages:
- Regulatory Compliance: In the U.S., the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) mandate pediatric assessments for certain drugs, while in Europe, the Pediatric Investigation Plan (PIP) is required for most new drugs. Early planning ensures alignment with these regulatory requirements, helping avoid delays and additional costs later on.
- Streamlined Development: Integrating pediatric considerations early can streamline the overall development process. Designing pediatric studies concurrently with adult studies, rather than as a separate initiative, can optimize timelines and resources.
- Addressing Unmet Needs: Children often have limited treatment options, especially for rare diseases. An early pediatric plan allows companies to consider the unique pharmacology, dosing, and safety needs of children, potentially speeding up access to new treatments for younger patients.
- Strategic Advantage: Demonstrating a commitment to pediatric populations early can enhance a company’s reputation, as it shows a dedication to addressing the needs of all patient groups. It may also open opportunities for exclusivity extensions or other incentives in various markets.
By addressing pediatric development in the early clinical stages, companies are better positioned to navigate regulatory requirements, optimize clinical trial designs, and address the therapeutic needs of pediatric patients efficiently.
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When should we scale-up manufacturing processes?
Scaling up drug manufacturing is a critical step that requires careful planning to ensure quality, safety, product efficiency, and regulatory compliance.
Generally, scale-up should begin during the later stages of clinical development (typically Phase 2 or early Phase 3) when proof of concept, dosing, and preliminary safety data are established.
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Related Glossary
Paediatric Investigation Plan (PIP) / Paediatric Study Plan (PSP)
Scientific Advice
Patient Engagement
Target Product Profile (TPP)
Pre-IND Meeting
Applicant for Clinical Trial Applications (CTA)
Quality-by-Design(QbD)
Questions? Get answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.