Fully Integrated Package Covering Phase I and II Studies

BioKinetic Europe can provide a fully integrated package covering Phase I and II studies. To extend our range of specialist services, we can tap into the resources of our partner organisations, to enable you to receive a range of services tailored to your study.

In collaboration with our international colleagues, we offer:

Services

• Study design
• Protocol development
• Clinical conduct
• Medical writing
• Regulatory affairs
• Statistical services
• Case report form design and printing
• Bioanalytical services
• Final study report for regulatory submission

Types of Studies

• First administration to man
• Vaccine
• Proof of concept
• TQTc
• Drug delivery
• Drug/drug interaction
• Pharmacodynamics
• Pharmacokinetics
• Food effect
• Bioequivalence
• Bioavailability

Our carefully chosen strategic alliances allow us to provide additional resources and services for our clients. If your needs dictate a total package, BioKinetic Europe will join forces with our partners, assuring you a comprehensive, tailor-made solution.

BioKinetic Clinical Applications

Based in Springfield Missouri, BioKinetic Clinical Applications conducts Phase I to IV clinical trials. Studies are carried out in a 268-bedded facility according to stringent FDA regulations. The firm’s highly developed information technology systems are available in Belfast and Springfield, allowing client access to tandardised procedures at both sites.

Dianthus Medical Limited

A UK-based organisation, Dianthus Medical Limited offers an extensive range of high quality medical writing, statistical consultancy, and clinical data management services. Their medical writing services include regulatory documents, such as protocols and clinical study reports, as well as communications writing, such as manuscripts for publication in peer-reviewed journals. They take great pride in maintaining the highest scientific standards in all their work.

Almac Group

Almac offers a wide range of integrated services from research, through development to delivery of finished products. BioKinetic Europe work with the Almac site in Craigavon, Northern Ireland, accessing bioanalytical services, including method development, validation and sample analysis. Studies can be performed to meet both US (FDA and EPA) and OECD GLP requirements. Almac is licensed for radio-labelled studies as well as cold material analysis.

QPS Pharmaceutical Services

BioKinetic Europe also collaborate with QPS Pharmaceutical Services, a global GLP-compliant contract laboratory supporting drug discovery and development. Based in Delaware, US, QPS have been providing high quality services to pharmaceutical and biotechnology clients worldwide since 1995. BioKinetic Europe have access to QPS’s bioanalytical expertise. QPS also specialise in drug metabolism and pharmacokinetics, biomarkers and early clinical research.