Questionnaire for the Selection of Clinical Research Organisations

Transcription

1 Dr. med. Bertram Ottillinger Life Sciences Consultancy Foehrenstrasse Brunnthal-Hofolding Germany Phone: +49 (0) Fax: +49 (0) Web: Questionnaire for the Selection of Clinical Research Organisations Status of Information: 1. CONTACT DETAILS Name and Address of Company Telephone Number Fax Number Contact Person, Job Title, Telephone Extension, Homepage and Address Page 1 of 11

2 2. COMPANY INFORMATION Company Structure Year when Company / Subsidiaries were founded Ownership Type Description of Business Activities Strategic Aim of Business Development Dr. med. Bertram Ottillinger Life Sciences Consultancy page 2 of 11

3 3. STAFF Please state the current headcount per location Location Administrative CRA / Monitor Project Manager Data Manager Statistician Safety QA Regulatory Affairs other of these board certified physicians of these freelance total Do you work with internal employees and/or with contractual staff (percentages)? Would you supply Job Descriptions, Staff CVs and Training Logs under a Secrecy Agreement? Your annual turnover of staff? Are studies managed by a staff pool or is defined staff allocated to a specific study? Dr. med. Bertram Ottillinger Life Sciences Consultancy page 3 of 11

4 Please give the average number of studies per staff function Average number of studies Function Phase I Phase II to III Phase IV Monitor CRA Project Manager Data Manager Statistician 4. CLIENT RELATIONS What percentage of clients last year were repeat clients? How frequently do you send status reports to the sponsor? What does a routine status report contain? Can you supply the sponsor with the study databases in a customised format? Do you provide online access to study databases for the sponsor? Dr. med. Bertram Ottillinger Life Sciences Consultancy page 4 of 11

5 5. CLINICAL OPERATIONS Please provide a detailed overview of your company s current clinical experience (please do not include experience of your staff gathered at former employers): Therapeutic Area No. of studies in phase I No. of patients/volunteers in phase I No. of studies in phase II to III No. of patients in phase II to III No. of sites in phase II to III No. of studies in phase IV / PMS No. of patients in phase IV / PMS No. of sites in phase IV / PMS Total No. of studies of these multinational studies of these studies monitoring only of these studies Data Management or Biometrics only Oncology Metabolism CV CNS Rheumatology Gastroenterology Ophthalmology Other: Dr. med. Bertram Ottillinger Life Sciences Consultancy page 5 of 11

6 Please provide an overview of the clinical experience of your staff gathered with former employers: Therapeutic Area No. of studies in phase I No. of studies in phase II to III No. of studies in phase IV / PMS Total No. of studies of these multinational studies of these studies Data Management or Biometrics only Oncology Metabolism CV CNS Rheumatology Gastroenterology Ophthalmology Other: Which 3 therapeutic areas have been most important during the last two years? Rank Therapeutic area % of clinical activities Dr. med. Bertram Ottillinger Life Sciences Consultancy page 6 of 11

7 In which continents and countries did your company perform clinical studies? Europe: Northern America: Southern America: Asia: Africa: Australia/New Zealand: Please indicate which internal or external standards your study reports follow Who takes over medical writing? Are you authorised to manage (ie manufacture, package, store, distribute, reconcile, destroy) study medication? Dr. med. Bertram Ottillinger Life Sciences Consultancy page 7 of 11

8 6. DATA MANAGEMENT AND STATISTICS Please indicate the type of Data Management System/s you use, the version/s and your experience: Please indicate your experiences with EDC/RDE in clinical studies (Number and phase of studies, type of software, online/offline) Please indicate the type/s of Project Management software you use, if any: Do you prospectively prepare a data management plan for each study? Where do you perform data entry internally or subcontracted? What coding dictionaries do you use? What is your average time from the CRF coming in-house and entry into the data base? How many queries do you generate on average per CRF page? Dr. med. Bertram Ottillinger Life Sciences Consultancy page 8 of 11

9 Do you provide query summary reports to the sponsor? What is your average time from last patient visit to data base lock if relevant, specify by study phase, country, etc? What is your average time from data base lock to first draft report if relevant, specify by study phase, country, etc? 7. QUALITY ASSURANCE / DRUG SAFETY Have you been inspected by the FDA or the EMEA during the preceding two years if yes, please give details? Do you employ internal and/or external auditors? Are you quality certified (eg according to ISO 9000)? Do you take over the processing of (Serious) Adverse Events / Adverse Drug Reactions according to the respective regulatory guidelines? If relevant, please indicate which software you use: Dr. med. Bertram Ottillinger Life Sciences Consultancy page 9 of 11

10 8. FINANCIAL INFORMATION Please provide your total revenues for the preceding two years Revenues per Geographic Area Total Revenues Year North America Europe Others Currency What percentage of the total revenues of the preceding year do your clinical activities (phase I to IV) represent? Clinical as % of Total Revenues Year North America Europe Others Total % Please estimate the share of the following services of your clinical activities Services % share of clinical activities Phase I study performance Phase II - III Phase IV Data Management Biometrics Studies with Generics Health outcome research Others: Total clinical 100 % Dr. med. Bertram Ottillinger Life Sciences Consultancy page 10 of 11

11 Please provide information on mergers and acquisitions in which you were involved during the preceding 5 years 9. COOPERATION Would you agree to an audit of your company, also on short notice (secrecy agreement will be provided)? Are you prepared to give information on the fulfilment of deadlines in recent studies (eg patient recruitment, preparation of reports) at such an audit? Can you submit a bid for a study on a structured form within three weeks? Please name any companies for which you prefer not to work: End Thank you for filling in this questionnaire Dr. med. Bertram Ottillinger Life Sciences Consultancy page 11 of 11