Clinical Study Planning and Design
SERVICES - PRECLINICAL AND NONCLINICAL DRUG DEVELOPMENT
Transforming a new drug or biologic entity into a treatment opportunity is a complex, expensive, and time-sensitive process. We help you navigate through the clinical development process through all clinical phases.
PHASE 1 STUDIES
Simplifying the drug development pathway while planning for contingencies requires clinical expertise and experience. CSSi LifeSciences™ is a proven partner that ensures that First-in-Human Phase 1 studies are designed to reduce time and expenses.
PHASE 2a/2b STUDIES
Based on the goals and early signs of safety and activity from the Phase 1 study, CSSi LifeSciences™ supports Phase IIa outcomes on an accelerated basis for approval through our integrated and adaptive study approaches. More importantly, our design methodology and operationalizing of studies increases success while considering the financial constraints. Following a successful proof-of-concept study, the product can progress to a Phase 2b or a Phase 3 study.
PHASE 3/3B STUDIES
CSSi LifeSciences™ has proven capabilities in advancing new drugs through late-phase clinical trials through well designed, Phase 3 studies, while obtaining rigorous data to satisfy multiple stakeholders, regulatory agencies, physicians and payers. Whether you need to position a product through comparative studies, develop line extensions or extend label claims, our process is designed to expedite study completion.
PHASE 4 AND EXPANDED ACCESS STUDIES
For a new drug to reach its intended market after launch, companies will need to:
- Show safety/efficacy data from larger populations
- Expand trust in target market
- Prove regulatory compliance
- Build recognition with key players through tactical marketing
Conducting an Expanded or Managed Access Program (EAP/MAP), whether under a Treatment IND, Emergency Use Protocol, Compassionate Use
or Named Patient Basis program, requires specialized strategies, skills and resources that are different than a conventional clinical study.
We have the expertise, experience, and infrastructure to help navigate the complex regulatory and logistical issues of expanded access programs worldwide. Our approach utilizes cost effective, centralized management of Expanded Access Programs, combined with integrated drug supply and logistics to support any size program or market segment.