SmartStudy™ & Feasibility
Risk-Based, Strategic Decision Making
Our comprehensive Feasibility Assessments and Gap Analysis ensure preclinical and CMC/GMP study protocols, clinical sites, and patient enrollment plans are expertly assessed and executed.
We also provide Gap Reports, which provides a risk-based analysis of the regulatory pathways to market, identifies gaps in the preclinical and nonclinical studies, potential predicates, and indications.
Feasibility Assessments review your protocol plans, and guide your clinical site selection and patient recruitment plans.
SMARTSTUDY™ & FEASIBILITY
Strategically designing a clinical study to differentiate your product is vital for emerging biopharmaceutical companies, whom often have extensive scientific in-house knowledge, but limited clinical trial design experience. Clinical studies need to be efficient and effective at each phase of development and must optimize the eventual marketing claims and Package Insert (PI), while meeting patient recruitment and retention goals.
CSSi LifeSciences™ has proven models that expedite time to market and decrease development costs. We focus our analysis on:
Site Feasibility Assessment & Site Selection
When determining the feasibility of sites for a study: the patient’s perspective must be considered, avoiding narrow geographic or demographic designs that exclude qualified sites is important. Globalization of the studies are paramount, with innovative country-specific recruitment tactics. We have worked with thousands of global sites and are well versed in the factors of site selection that impact a study.
- Site, physician, and KOL network of over 700 clinical sites
- Country specific feasibility review
- Worldwide clinical trials recommendations for country/site distribution to ensure local regulatory and minimum patient recruitment samples
- Site negotiation, contracting, ethical review
- SmartStudy™ start up and site training
Clinical trial development must include patient centricity and input to ensure success and avoid roadblocks. Over 80% of industry clinical trials don’t meet recruitment targets on time due to patient recruitment challenges.
The biggest challenges in conducting a successful clinical study tend to be identifying, measuring and understanding real world patient
population and the implications of the study design and product marketing claims.
To remedy these challenges we offer:
- Patient pathway development, mapping, and opportunity analysis
- Enrollment and marketing plans
- Local Enrollment Specialists (LES)
- Social media support services
- Creative media and design
- Media buying and placement
- Patient advocacy and outreach