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Academic Clinical Trials

The Almac office in Durham, North Carolina was part of the Duke Clinical Research Institute from 1990-2000 and provided clinical pharmacy, packaging, distribution and supply chain services. All of the studies handled during this time were physician-led and academically based. As a result of our academic origins many of our Project Leaders are pharmacists and we have continued in this model after becoming part of Almac. We found that project staff needed to understand disease states, how patients move through the hospital and pharmacy best practice when working directly with investigators. Our Project Leaders are involved with projects from writing the CTM section of the protocol through to reconciling drug returned from the clinical sites at close out.

The Almac Durham facility is a licensed pharmacy. Our goal is to provide clinical supplies that are prepared in compliance with GMP regulations and support the interaction between the health care provider and the patient. It is our unique blend of pharmacy practice and clinical trial experience that allow us do this.

In addition to our core contract services, Almac offer the following unique services to our clients.

Clinical Input

Write the CTM section of protocol
Review protocol for pharmacy feasibility
Communicate with site pharmacist and study personnel.
Prepare patient and site educational materials

Training and Monitoring

Train sites on drug preparation
Monitor drug accountability records
Participate in investigator and monitor training
Track dosing accuracy

Study Materials

Dosing nomograms
Drug preparation tables
Dosing tables
Pharmacy manuals

Supply Chain Management

Develop drug forecast
Determine packaging and materials plan
Determine site/depot supply parameters
Monitor and update forecast and kit demand

Drug Kits and Labels

Kit design in support of the protocol
Development of label text and translations
Packaging design

Clinical Pharmacy

Drug compatibility during IV administration
Create drug preparation guidelines
Clinical call services