Since 2001, Clinilabs has successfully completed over 190 clinical trials involving healthy, adult human volunteers and specialty patient populations. Overall, our staff has accrued experience in over 750 clinical studies, offering clients the service capacity of a big CRO - delivered by an organization that is right-sized and priced for early phase projects.
- Microdosing
- Exploratory (non-drug) studies
- First-in-human studies
- Single Ascending Dose (SAD)
- Multiple Ascending Dose (MAD)
- Dose-ranging studies
- Bioequivalence and bioavailability studies
- Pharmacokinetic studies
- Pharmacodynamic studies
- Food effect studies
- Drug-drug interaction studies
- Ethnic bridging studies
- Thorough QT and cardiac intensive studies
- Sleep and wakefulness studies
- Multiple therapeutic area specialties
- Proof-of-concept studies
- Phase IIa and IIb studies
Our staff has experience in the following therapeutic areas:
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- Psychiatry
- Neurology
- Sleep
- Endocrinology
- Cardiology
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- Analgesia
- Dermatology
- Infectious disease
- Oncology
- Ethnic bridging
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Medical device trials typically are smaller than the pivotal studies performed with investigational new drugs. Therefore, client companies may benefit from working with an organization that has expertise in managing trials of this size. Clinilabs has performed several premarket device studies in order to ensure that our clients submit documents and data that meet FDA standards. Our prior experience with device studies includes:
- Light delivery devices
- Respiratory care devices
- Neurostimulation devices
- Surgically implanted devices
When you’re looking for a full-service CRO to handle multiple Phase I studies in your clinical development program, look no further. Clinilabs offers program packages that deliver complete, “regulatory ready” data portfolios that prepare investigational drugs for successful Phase II and III development programs. Program packages enable clients to pre-plan all of the studies required in an early-phase development program, working with one team of people who will manage and execute projects within the program. This approach offers efficiencies of time and expense that enable clients to achieve deep cost savings and discounts.
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