Leading Clinical Research

Transcription

1 Leading Clinical Research We will take you through the labyrinth of clinical trials directly to your target innovative, safe and effective drug or medical device Track Record

2 On the following slides you will find a sample of projects that Leading Clinical Research has realized since For more information you can contact:

3 Phase III Registration trials (phase III) Respiratory tract infections (pediatric study) responsibility for complex project incl. medical writing, statistics, DM, monitoring activities, pharmacovigilance. Bronchial Asthma (pneumology) responsibility for PM and monitoring activities. 20 patients. Brest cancer (oncology) responsibility for PM and monitoring activities. 12 patients. Ulcerative colitis (gastroenterology) responsibility for PM and monitoring activities. 19 patients.

4 Phase III Registration trials (phase III) Thermal burns (Burns and Reconstructive Surgery) responsibility for 2 countries, PM and monitoring activities. Revmatoid arthritis (rheumatology) responsibility for PM and monitoring activities. 50 patients. Coronary syndrome (cardiology) responsibility for PM activities. 355 patients. Prevention of Thrombotic Events (cardiology) responsibility for monitoring activities. 300 patients. Prevention of Atherothrombotic Ischemic Events (cardiology) responsibility for PM activities patients.

5 Phase III Registration trials (phase III) In Vitro Fertilisation (gynecology) international study, responsibility for leading 5 EU countries (PM and monitoring), 300 patients to be. Diabetes Mellitus (diabetology) responsibility for PM and monitoring activities. 200 patients Overactive bladder (urology) responsibility for monitoring activities. 50 patients Psoriasis (dermatology) responsibility for PM activities. 24 patients

6 Specific/rare diseases Specific/rare diseases trials Neurosurgery - aneurysmal subarachnoid hemorrhage Managing 2 countries Influenza (phase II) LCR managing 3 countries, CR best recruiter Chronic cancer pain (phase II) 2 countries, complex project incl. MW, DM, PM, MV Substitution therapy in Heroin Users safety study, 25 patients, PM activities Deep neuromuscular blockade (phase IV)

7 Specific/rare diseases Specific/rare diseases trials Streptococcus pneumoniae vaccine pediatric study, phase II, 240 patients enrolled, (Czech Republic was the best recruiting country). Responsibility for monitoring activities. Herpes zoster vaccine Phase III, responsibility for monitoring activities. Non-operable chronic thromboembolic pulmonary hypertension Responsibility for regulatory submissions, contract management, monitoring

8 Medical Devices Clinical Investigations of Medical Devices Cervical Intraepithelial neoplasia (phase II) Combined product medicinal product & medical device. Responsibility for PM, RA and SM in 2 countries. 150 patients. RA inspection on 4 sites without any finding. Clinical investigation - complex project incl. MW, DM, PM, MV Clinical investigation - complex project incl. MW, DM, PM, MV

9 Medical Devices Clinical Studies of Medical Devices International clinical study, 7 countries, 150 patients. Responsibility for all activities incl. PM, MV, DM, statistics. Retrospective data collection. Responsibility for PM and MV. Retrospective and prospective data collection. Complex project incl. MW, DM, PM including regulatory submission, MV Burns Treatment (traumatology) Retrospective data collection. Responsibility for PM and monitoring activities. 101 patients. Influenza (phase II) Combined product (medicinal product + medical device with CE mark). LCR managing 3 countries, CR best recruiter.

10 NIS Non-interventional studies Ulcerative Colitis responsibility for PM, 50 patients. Chronic Low Back Pain responsibility for PM, 60 patients. Chronic Hepatitis C responsibility for PM and monitoring activities, 400 patients. Psoriasis responsibility for PM, 48 patients.

11 NIS Non-interventional studies Contraception responsibility for PM and monitoring, 1850 patients. Ophthalmology - cataract responsibility for PM and monitoring, 200 patients. Chronic Hepatitis C responsibility for data management and statistics. Labour induction (gynecology) responsibility for data management and statistics. Burn wounds responsibility for PM, monitoring, data management and statistics, 200 patients.

12 Medical Writing Medical Writing Interventional clinical trials/investigations Algesiology Cancer pain (phase II) Pilot trial complex project incl. preparation of the study protocol, amendments, CRF design, ICFs, patient diaries and cards. Paediatrics / Immunology (phase III) Pivot trial - complex project incl. preparation of the study protocol, CRF, ICFs, patient diaries and cards. Gynaecology / Immunology (phase III) Pivot trial - complex project incl. preparation of the study protocol, CRF, ICFs, patient diaries and cards.

13 Medical Writing Medical Writing Interventional clinical trials/investigations pivot trial - complex project incl. preparation of the clinical investigational plan, CRF design, ICF pivot trial - complex project incl. preparation of the clinical investigational plan, CRF design, ICF complex project incl. preparation of the clinical investigational plan, CRF design, ICF Infectology influenza (phase II) Pilot international trial protocol preparation

14 Medical Writing Medical Writing Non-interventional clinical trials/investigations Cardiology Atrial fibrillation Observational register complex project incl. preparation of the study protocol, CRF, ICFs complex international project incl. preparation of the clinical investigational plan, CRF design, ICF Burns (traumatology) complex project incl. preparation of the clinical investigational plan, CRF, ICF

15 Data Management/Statistics Medical Writing Data Management/Statistics Traumatology burns Data management, statistics, preparation of a final/clinical evaluation report Obstetrics labor preinduction Data management, statistics, preparation of a final/clinical evaluation report Opthalmology cataract Data management, preparation of a statistical analysis plan Dermatology acne vulgaris Data management, statistical analysis plan preparation & statistics, preparation of a final report Urology recurrent urinary tract infections Data management, statistical analysis plan preparation & statistics, preparation of a final report

16 What we are proud of: 54 projects, more than 600 sites and subjects 100% approved trials (Regulatory Authority, Ethics Committees)