By Phase Overview
Our services light the way through the complexities of clinical development.
Allucent’s regulatory, product development, and clinical research solutions are purpose-built for the needs of small and mid-sized biotechs.
Allucent has more than 30 years of experience delivering solutions globally for small and mid-sized biotechs.
We understand how to develop and implement the right strategy throughout the lifecycle of your product, from inception to approval. Our proven expertise allows us to embrace complexity, which is exactly why we’re the right partner to help manage your clinical trial.
From study startup to trial execution, we’re adept at overcoming the challenges that routinely appear in complex therapeutic areas, indications, and modalities.
The drug development lifecycle
Targeted for small and mid-sized biotech companies in areas that are import to your business cycle, we have the capabilities of a larger CRO but customized to meet your unique needs.
NONCLINICAL
- Development Planning and Gap
- Sample size and power calculations
- Health authority meetings
- Regulatory filings IND/IMPD/CTA
PHASE 1
- Clinical pharmacology plan
- Study protocol
- First in human proof of principal
PHASE 2
- Rare disease designation
- Study initiated
- Interim analysis
- In-house database lock
- Results
PHASE 3
- Study initiated
- In-house database lock
- Regulatory filings BLA/NDA/MAA
APPROVAL & PRODUCT LAUNCH
- Post-submission rapid response
- Inspection readiness
- Advisory meetings
- Brief packet preparation
Expertise that solves your complex challenges
People
Our deep bench of tenured experts understand the journey your organization faces. The depth of our experience gives us the foresight to proactively address potential operational, scientific, and regulatory issues to ensure you a smooth transition when completing a trial or moving into IND submission.
Processes
Our experts work with you from protocol development to designing a study that is scientifically meaningful and operationally feasible, all while navigating global regulatory challenges that are so common in complex clinical trial design. From study start up to trial execution, we’re adept at overcoming the challenges that routinely appear in complex therapeutic areas, indications, and modalities. Whether it is a regulatory quandary that needs to be solved or operational and scientific hurdles that need to be cleared, Allucent has proven expertise to tackle your most complex challenges.
Complex Therapeutic Areas
Our team has decades of experience designing and executing clinical trials in therapeutic areas including oncology and hematology, rare disease and orphan drugs, cell and gene therapy, gastroenterology and hepatology, and central nervous system.