Care. Commitment. Compassion.

Named Patient Supply

Healthcare professionals worldwide are faced with the challenge of treating patients who need a medicine that is not locally available to them. The drug may not yet be launched in their country, been discontinued, or is simply in short supply. In these instances, physicians and pharmacists need to source and dispense patient specific, difficult-to-obtain treatment, often on an urgent basis.

One-World has been supplying healthcare professionals these treatments for over 20 years. We understand the urgency and take this into consideration as we promptly and securely facilitate delivery of these urgent medicines.

Clinical Trial Supply

Clinical Trial Supply has been a driving force of One-World’s business since the company was founded in 2001. We offer efficiency, dependability, and confidentiality to sponsors, CRO’s and institutions procuring pharmaceuticals for clinical trials. Because of our extensive international experience, we have developed strong supplier and manufacturer relationships worldwide.
We can:

  • Secure the product
  • Obtain support documentation
  • Consolidate and ship to the desired location round the world

We attend to all the details, such as:
  • Specific lot numbers
  • Specific shelf life
  • Chain of custody documentation
  • Special delivery dates
  • Special shipping requirements

Managed Access Programs

One-World works with U.S. manufacturers and distributors to provide investigational or unapproved drugs to providers so they can treat their patients for serious or life-threating diseases or conditions. Managed access terminology includes locally defined pre-approval access mechanisms such as “Compassionate Use”, “Expanded Access”, “Temporary Authorization (ATU), “Named Patient Supply” among others.

Third Party Logistics

Logistics outsourcing for “high touch – high value” biologics has become a recommended practice for the storage and handling of critically sensitive products. Traditional logistics companies are not well versed and try to incorporate these services into their existing high-volume business models. One-World has been in the business of handling specialty pharmaceuticals for over 20 years, evolving with the industry, and always improving our processes. Our clients include:

  • Healthcare institutions requiring controlled medicines not commercially available in their country.
  • Manufacturers that need to export controlled drugs outside the USA.
  • Clinical Research Organizations running multi-country studies of controlled drugs.

Shortages and Stock Outs

Medicine shortages can occur for many reasons:

  • Manufacturing difficulties
  • Quality defects
  • Raw material supply issues
  • Increased demand
  • Supply chain disruptions
  • Discontinuations by manufacturers

We leverage our extensive nationwide supply chain footprint to secure the necessary medicines to meet the temporary demand of shortages.

Specialty Drugs and Biologics

Typically treating chronic or terminal conditions, specialty drug treatments are the fastest growing pharmaceutical sector in the world. Most specialty drugs are first launched in the U.S. with registration in the E.U. to follow. Based on the patient population in international markets, the manufacturers may not seek to extend registration.

One-World steps in to fill the distribution gaps. We work with international healthcare entities to secure these products for their patients using ethical regulatory pathways available for this purpose.

Orphan Drug Distribution

Orphan drugs are defined as “drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S. or less than 5 per 10,000 individuals in the European Union.”

We provide orphan drug distribution outside the U.S. by:

  • Using ethical authorized supply channels while maintaining the highest level of supply chain security
  • Aligning with rare disease advocacy organizations and physicians’ groups to identify unmet patient needs
  • Navigating government importation regulations to make sure treatments are received in a timely manner

Export of Controlled Drugs

Our fully licensed and trained staff works closely with the Atlanta office of the USDEA, the state of Georgia Drugs and Narcotics Agency, and the USDEA export office in Washington, DC. We provide CII-CV international shipping services and sales for manufacturers and facilities that do not have the proper licenses or expertise.