We understand that on-study changes to early phase study designs and dosing are frequent and so our study strategy for study database design and reporting is built around flexibility and rapid implementation.
We use eSource data collection procedures in our clinical units and a joint eSource/eCRF database.
We assign a single Project Manager for all drug product, clinical and data sciences activities.
When you need compliant datasets, enlist our experts that understand CDISC’s impact on early phase studies.
Our systems mean we can reduce data query rates, data transcription and timelines.
Our statistical, pharmacokinetic and scintigraphic experts understand clinical pharmacology studies and their specialized challenges.
As a CDISC Gold Member, we have built CDISC standards into all our data management and statistical procedures.
Integrated development platform that is proven to reduce timelines by >12 months.
Clinical trial supplies for oral, injectable and inhaled dosage forms.
Phase I healthy volunteer studies & 14C Human ADME.
Tech transfer, Process Scale-Up & Optimization, Lifecycle Management.
PR&D, Custom Synthesis and drug substance characterization.
Simple & complex dosage forms: PIB, PIC, Tablets, Poorly Soluble, Modified-Release, Pediatrics.
Rapid bioanalytical data in discovery, pre-clinical & clinical.
Rapid access to clinical data & results to accelerate drug development.
Holistic scientific advice at each stage of drug development.
Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast.
Our scientists can help you overcome the drug delivery challenges presented by your molecule for all dosage forms and routes of delivery.
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