LeobenResearch

Medical and Scientific Services

We strive for excellence in delivering superior quality services as we build our reputation of provider of advanced medical knowledge solutions for clinical trials in the global market

Our medical and scientific services are in general delivered within a cross-functional matrix organisation, where the aim of the medical lead role is to provide medical expertise across the different functional groups involved in the delivery of complex drug development programs. We provide medical expertise to the clinical development strategy, protocol design and development, product safety management risk, Investigator’s Brochure and other regulatory essential documents, clinical study analysis and reporting, data publication, trial medical monitoring and safety assessment. Furthermore, the medical lead provides expertise and knowledge to support new formulation development, preclinical safety & toxicology, genetics, clinical operations, clinical pharmacology, clinical quality assurance, brain imaging, drug safety, biostatistics, and regulatory affairs.

Our track record of successful medical knowledge consulting services for sponsor-directed clinical trials throughout the clinical development process and product life cycle

Medical Affairs
  1. Naldemedine, GI-Pain Therapeutic Area , European Medical Affairs at Shionogi
Phase 2 Studies
  1. A Randomised, Double Blind, Placebo Controlled, Parallel Group, Dose-Response, Add-on, Phase 2, Multicentre Study to Evaluate NX-2001 for the Treatment of Suicidal Ideation to Prevent Suicidal Behaviour in Patients Receiving Standard of Care (SOC) Treatment for Suicide Risk Management
  2. Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia (IEM)
  3. A Safety And Tolerability Study Of PF-05089771 In Healthy Subjects And In Subjects With Osteoarthritis Of The Knee
  4. Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
  5. A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)
  6. Efficacy Of PF-04531083 In Treating Post-Surgical Dental Pain
  7. Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke Details on the PF-03049423, a PDE5 inhibitor, in acute ischemic stroke study can be found at https://clinicaltrials.gov/ct2/show/NCT01208233
  8. A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD). Raters Training and Qualification.
Phase 1 Studies
  1. A Single Dose Escalation Study In Healthy Volunteers To Determine The Pharmacokinetics, Safety And Tolerability Of PF-05089771 In Healthy Volunteers
  2. The Safety and Tolerability of PF-05089771 Investigated in Healthy Subjects Over a 14 Day Dosing Period.
  3. Safety And Tolerability Study Of BID Titration Scheme With PF-05089771
  4. A Study Comparing PF-05089771 TS Tablet to PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And Fed State
  5. A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State
  6. Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion
  7. Drug-Drug Interaction Study With PF-05089771
  8. Safety and Tolerability Study of Multiple Doses of PF-06305591
  9. Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
  10. A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162
  11. A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two Age Groups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
  12. Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare
  13. Cold Pressor Test to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male Subjects