At Berg, LLC we are driven by our passion to bring meaningful improvements to the lives of patients. To do this, Berg conducts clinical trials to assess the safety and efficacy of investigational drugs, so that we may obtain approvals and provide these drugs to the populations in need.
Participating in clinical trials is the preferred way for patients to access drugs prior to FDA approval. An alternative pathway for patients to gain access to investigational drugs for serious diseases or conditions is expanded access, also known as “compassionate use”. There are strict regulations for patients to be eligible for expanded access, for which your physician can apply. In close cooperation with your physician, Berg, under special circumstances, is willing to evaluate patient requests for expanded access to its clinical product candidates in the United States.
These circumstances are as follows:
- The patient’s disease is serious or life-threatening.
- There are no alternative therapies or clinical trials available for this disease.
- There is data to support the safety and the efficacy of the product in question.
- The risk/benefit to the patient is acceptable.
- There is no indication that this provision will hinder further development of the investigational drug.
- There is adequate drug supply available.
- The administration of the drug will be overseen by an experienced physician licensed in the United States who is able to administer the drug per instruction, and monitor the patient’s status while on drug.
- The patient is able and willing to give a fully informed consent and comply with the safety and monitoring requirements defined by Berg
All questions and requests regarding Berg’s expanded access or compassionate use programs should be submitted to Berg by email: email@example.com. We will acknowledge receipt of the query within five working days.
At any point expanded access or compassionate use can cease at the discretion of Berg. This policy may change without notice.
For further information on available clinical trials and expanded access programs, visit www.clinicaltrials.gov and search for trials where Berg is the sponsor.