Published on Monday October 31, 2016

Smooth Drug Development October 2016 News Release

In October Smooth Drug Development has started several new projects:
  • We were awarded with a bioequivalence trial with capecitabin in oncology patients.
  • We are starting medical writing activities in a phase III trial with an oncology compound.
Smooth Drug Development team has reached milestones in several ongoing trials:
  • We enrolled first patients in a phase III trial in patients with erectile dysfunction.
  • We enrolled first patients in a pain management phase III clinical trial.
  • We performed a site initiation visit in our acute respiratory infections phase III clinical trial. First patients are expected to be enrolled within 1 week.
  • We performed an initiation visit in a bioequivalence trial with desmopressin.
  • A close out visit was performed in a phase I trial in healthy volunteers.
  • A final Clinical Study Report of a bioequivalence trial with a combination of Lamivudine + Zidovudine is sent to the client.
  • A final Clinical Study Report of a phase III clinical trial with an innovative drug in patients with hemispheric ischemic stroke in the acute and early recovery period is sent to the client.
Our team received an ICH GCP training in October. Several other trainings in ICH GCP are planned in November.
Our company adheres to the PDCA principle and continuous improvement; therefore, we are updating and implementing new Standard Operating Procedures.
As a part of the Business Continuity Management (BCM) Policy implemented in our company, we performed a planned fire alarm evacuation, which confirmed that the company could ensure that it services can continue within a short period of time when disrupted.