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2017 GxP Audits

Vendor Audit.Status In.USA.or.OUS Location Services.Audited GxP.Area Audit.Type Audit.Method Proposed.Quarter VRTX.QA.Coordinator GxP.Auditor CSQA.Auditor TW.Report.Number Date.of.Intake Date.Q.sent Date.Q.Rcvd Date.On.Site.Scheduled Audit.Start.Date Audit.End.Date Date.Final..Report.Due Date.of..Completion Completed Notes
Vendor1 Not In Scope OUS Bonn, Germany consulting/cenral budget negotiations for sites lcoated in Germany, Vendor (select studies), and website posting (select studies) GCP Qualification None Q2 JMD (Unknown) (Unknown) (Unknown) 1/5/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor2 Closed USA Princeton, NJ CRO GCP Qualification On Site Q1 JMD MR DF 22552 1/5/17 (Unknown) (Unknown) (Unknown) 2/14/17 2/16/17 3/15/17 3/16/17 Delayed
Vendor3 Pending OUS Munich, Germany (Unknown) GCP Qualification TBD Q3 JMD (Unknown) (Unknown) (Unknown) 1/5/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor4 Completed USA Indianapolis, IN Life cycle of data during the sample processing stages; Study start up; Translation of protocols into lab tests and how they are performed, documented, and managed; Global processes and harmonization between other Vendor sites; Linkage of systems at other Vendor labs and usage of a centralized system for data; Robust process in place for third party labs and oversight of transferring samples at different locations; Tech transfer process; Sample management GCP Qualification On Site Q1 JMD MR AA (Unknown) 1/5/17 (Unknown) (Unknown) 6/5/17 7/12/17 7/13/17 8/12/17 8/11/17 On-time
Vendor5 Closed OUS Heidelberg, Germany (Unknown) GCP Qualification On Site Q1 JMD PK DF 22501 1/13/17 (Unknown) (Unknown) (Unknown) 2/7/17 2/8/17 3/10/17 3/10/17 On-time
Vendor6 Closed OUS Ontaria, Canada Registry Database GCP Qualification Questionnaire Q1 JMD JO LG 22620 1/13/17 1/19/17 2/1/17 (Unknown) (Unknown) (Unknown) 3/3/17 3/3/17 On-time
Vendor7 Closed OUS Oakville, Canada (Unknown) GCP Qualification Questionnaire Q1 JMD JO LG 22372 1/13/17 1/19/17 2/2/17 (Unknown) (Unknown) (Unknown) 3/3/17 3/3/17 On-time
Vendor8 Closed USA Durham, NC (Unknown) GCP Requalification On Site Q1 JMD KB MD 23134 1/13/17 (Unknown) (Unknown) 1/13/17 2/20/17 2/23/17 3/25/17 3/24/17 On-time
Vendor9 Closed USA Mattawan, MI General Toxicology Genetic Toxicology Carcinogenicity Safety Pharmacology Analytical Bioanalytical Toxicokinetics GLP Requalification On Site Q2 MM RD AK 23135 1/13/17 (Unknown) (Unknown) 3/17/17 4/25/17 4/27/17 5/27/17 5/19/17 On-time
Vendor10 Closed USA Rockville, MD Genetic Toxicology Mammalian Toxicology Clinical Pathology Safety Pharmacology Histopathology Bioanalytical Analytical Toxicokinetics GLP Requalification On Site Q1 MM RD DF 22648 1/13/17 (Unknown) (Unknown) 3/8/17 3/21/17 3/23/17 4/22/17 4/21/17 On-time
Vendor11 Not In Scope USA Ashland, OH General Toxicology Genetic Toxicology Carcinogenicity Safety Pharmacology Analytical Bioanalytical GLP Requalification None Q1 MM (Unknown) TBD (Unknown) 1/13/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor12 Closed USA Emeryville, CA (Unknown) GVP Qualification Questionnaire Q1 DL (Unknown) LG 22379 1/25/17 1/26/17 3/23/17 (Unknown) (Unknown) (Unknown) 4/22/17 4/10/17 On-time
Vendor13 Closed OUS Prague, Czech Republic (Unknown) GVP Qualification Questionnaire Q1 DL (Unknown) LG 22192 1/25/17 1/26/17 3/1/17 (Unknown) (Unknown) (Unknown) 4/1/17 4/4/17 Delayed
Vendor14 Closed OUS Petach Tikva, Israel (Unknown) GVP Qualification Questionnaire Q1 DL (Unknown) LG 22203 1/25/17 1/27/17 2/28/17 (Unknown) (Unknown) (Unknown) 3/30/17 4/4/17 Delayed
Vendor15 Closed OUS Richmond, United Kingdom (Unknown) GVP Qualification Questionnaire Q1 DL (Unknown) LG 22381 1/25/17 1/26/17 3/2/17 (Unknown) (Unknown) (Unknown) 4/1/17 4/10/17 Delayed
Vendor16 Closed OUS Chandigah, India (Unknown) GVP Qualification Questionnaire Q1 DL (Unknown) LG 22223 1/25/17 1/26/17 3/8/17 (Unknown) (Unknown) (Unknown) 4/7/17 3/23/17 On-time
Vendor17 Closed OUS Auckland, New Zealand (Unknown) GVP Qualification Questionnaire Q1 DL (Unknown) LG 22380 1/25/17 1/26/17 3/8/17 (Unknown) (Unknown) (Unknown) 4/7/17 4/27/17 Delayed
Vendor18 Not In Scope OUS Vincenza, Italy Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution, Test Articles, Reference Standard GMP Requalification None Q1 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) 2/7/17 2/21/17 2/24/17 3/26/17 (Unknown) (Unknown)
Vendor19 Not In Scope OUS Ponte Cremenaga, Swizerland Spray Dried Dispersion Dry Powder Inhaler Characterization GMP Qualification None Q1 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor20 In Progress OUS Dudley, United Kingdom Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution, Test Articles, Reference Standard GMP Requalification On Site Q1 GN TB TB 21871 2/8/17 (Unknown) (Unknown) 5/4/17 5/10/17 5/10/17 6/9/17 (Unknown) (Unknown)
Vendor21 In Progress USA Malvern, PA DS Intermediate and/or DS Mfg., Analytical Services, Warehouse & Distribution, Test Articles, Reference Standard GMP Requalification On Site Q1 GN RN DF 21875 2/8/17 (Unknown) (Unknown) 5/4/17 6/12/17 6/13/17 7/13/17 (Unknown) (Unknown)
Vendor22 Completed USA Bensenville, IL Warehouse & Distribution, Brokerage / Transportation GDP Qualification On Site Q1 GN LDS CR 21876 2/8/17 (Unknown) (Unknown) Week of 20 Feb 2/20/17 2/21/17 3/23/17 3/23/17 On-time
Vendor23 Completed USA High Point, NC Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution; Test Articles, Reference Standard GMP Requalification On Site Q2 GN LDS DF 21879 2/8/17 (Unknown) (Unknown) 3/24/17 4/3/17 4/4/17 5/4/17 5/4/17 On-time
Vendor24 In Progress USA Charles City, IA Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Qualification On Site Q2 GN LDS AA 21880 2/8/17 4/20/17 (Unknown) 5/4/17 6/20/17 6/21/17 7/21/17 (Unknown) (Unknown)
Vendor25 In Progress OUS Tokyo, Japan Raw Material Mfg., Starting Matertial Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Qualification On Site Q2 GN TB TB 22033 2/8/17 (Unknown) (Unknown) 5/4/17 6/26/17 6/27/17 7/27/17 (Unknown) (Unknown)
Vendor26 Pending OUS Jiuzhou, China Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Qualification On Site Q2 GN TB TB (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor27 Pending OUS Goa, India Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Qualification On Site Q2 GN TB TB (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor28 Not In Scope USA Secaucus, NJ Comparator/co-medication purchase; ability to outsource placebo development and manufacturing to a third party GMP Qualification None Q2 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor29 Not In Scope OUS Brampton, Canada Warehouse & Distribution GDP Requalification Q in 2016 Q2 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor30 Not In Scope OUS Ankara, Turkey Warehouse & Distribution GDP Qualification None Q2 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor31 Not In Scope OUS Harsewinkel, Germany Warehouse & Distribution GDP Qualification None Q2 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor32 Not In Scope OUS Moscow, Russia Warehouse & Distribution GDP Qualification None Q2 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor33 In Progress USA Whippany, NJ DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Requalification On Site Q2 GN SK JR 21870 2/8/17 (Unknown) (Unknown) 5/3/17 5/31/17 6/1/17 7/1/17 (Unknown) (Unknown)
Vendor34 Scheduled USA Wilmington, NC Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Requalification On Site Q2 GN (Unknown) CL (Unknown) 2/8/17 (Unknown) (Unknown) 6/30/17 10/10/17 10/11/17 11/10/17 (Unknown) (Unknown)
Vendor35 Scheduled OUS Jiande Zhejiang, China Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution, Test Articles, Reference Standard GMP Requalification On Site Q2 GN SK AK (Unknown) 2/8/17 (Unknown) (Unknown) 9/27/17 11/27/17 11/28/17 12/28/17 (Unknown) (Unknown)
Vendor36 In Progress USA Lancaster, PA Analytical Services, Microbiology Testing Services GMP Requalification On Site Q2 GN RJC BM 21888 2/8/17 (Unknown) (Unknown) 8/3/17 8/31/17 8/31/17 9/30/17 (Unknown) (Unknown)
Vendor37 Scheduled USA Rockford, IL Pkg. & Labeling Mfg., Analytical Services, Warehouse & Distribution GDP Requalification On Site Q2 GN CT PW 21889 2/8/17 (Unknown) (Unknown) 9/20/17 10/12/17 10/13/17 11/12/17 (Unknown) (Unknown)
Vendor38 In Progress OUS Deajeon, Korea Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Requalification On Site Q2 GN TB TB 21890 2/8/17 (Unknown) (Unknown) 5/4/17 6/29/17 6/30/17 7/30/17 (Unknown) (Unknown)
Vendor39 In Progress OUS Loures, Portugal Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution, Test Articles GMP Requalification On Site Q2 GN (Unknown) WS (Unknown) 2/8/17 (Unknown) (Unknown) 5/4/17 9/27/17 9/29/17 10/29/17 (Unknown) (Unknown)
Vendor40 In Progress USA Bend, OR Starting Matertial Mfg., DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution, Test Articles, Reference Standard GMP Requalification On Site Q2 GN (Unknown) WS 21892 2/8/17 (Unknown) (Unknown) 5/2/17 8/1/17 8/2/17 9/1/17 (Unknown) (Unknown)
Vendor41 Not In Scope USA Highland Park, NJ 503a Compounding Services GMP Requalification None Q2 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor42 In Progress OUS Dartford, United Kingdom DS Intermediate and/or DS Mfg., Analytical Services, Warehouse & Distribution, Test Articles, Reference Standard GMP Requalification On Site Q3 GN TB TB 21897 2/8/17 (Unknown) (Unknown) 5/4/17 7/10/17 7/10/17 8/9/17 (Unknown) (Unknown)
Vendor43 In Progress OUS Courroux, Switzerland Starting Matertial Mfg., DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Requalification On Site Q3 GN SK AA 21900 2/8/17 (Unknown) (Unknown) 6/30/17 9/18/17 9/19/17 10/19/17 (Unknown) (Unknown)
Vendor44 In Progress OUS Latina, ltaly Starting Matertial Mfg., DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Requalification On Site Q3 GN JR ES 21901 2/8/17 (Unknown) (Unknown) 6/30/17 9/21/17 9/22/17 10/22/17 (Unknown) (Unknown)
Vendor45 Cancelled USA Knoxville, TN Analytical Services GMP Requalification None Q3 GN EZ PW 21902 2/8/17 (Unknown) (Unknown) 6/26/17 9/19/17 9/19/17 10/19/17 (Unknown) (Unknown)
Vendor46 Pending USA Brooks, KY Pkg. & Labeling Mfg., Warehouse & Distribution GMP/GDP Requalification On Site Q4 GN Vendor3 (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor47 Pending USA Reno, NV Pkg. & Labeling Mfg., Warehouse & Distribution GMP/GDP Requalification On Site Q4 GN Vendor3 (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor48 Scheduled USA Horsham, PA DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Requalification On Site Q4 GN (Unknown) WS (Unknown) 2/8/17 (Unknown) (Unknown) 9/14/17 10/24/17 10/25/17 11/24/17 (Unknown) (Unknown)
Vendor49 Pending OUS Rydalmere, Australia Warehouse & Distribution GDP Requalification Questionnaire Q4 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor50 Cancelled USA Somerset, NJ Starting Matertial Mfg., DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Requalification None Q4 GN RN BM 21907 2/8/17 (Unknown) (Unknown) 8/3/17 9/19/17 9/20/17 10/20/17 (Unknown) (Unknown)
Vendor51 Pending OUS Visp, Switzerland Raw Material Mfg., Starting Material Mfg., DS Intermediate and/or DS Mfg., DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution and Cell Bank Storage GMP Requalification On Site Q4 GN (Unknown) TB (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor52 In Progress USA Columbia, SC Starting Matertial Mfg., DP Intermediate and/or DP Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Requalification On Site Q4 GN (Unknown) DF 21911 2/8/17 (Unknown) (Unknown) 8/3/17 9/26/17 9/27/17 10/27/17 (Unknown) (Unknown)
Vendor53 Not In Scope OUS Starnberg, Germany Device Mfg. GMP Qualification (Unknown) Q4 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor54 Not In Scope USA Midlothian, VA Device Mfg. GMP Qualification (Unknown) Q4 GN (Unknown) (Unknown) (Unknown) 2/8/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor55 Closed USA Mason, OH Pathology services GLP Qualification On Site Q1 MM RD CL 23131 2/9/17 5/8/17 5/19/17 3/31/17 5/24/17 5/24/17 6/23/17 6/23/17 On-time
Vendor56 Not In Scope USA Lenexa, KS Bioanalytical GLP Requalification None Q1 MM (Unknown) (Unknown) (Unknown) 2/9/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor57 Not In Scope OUS Montreal, Canada Genetal Toxicology Drug Metabolism Toxicokinetics GLP Requalification None Q2 MM (Unknown) (Unknown) (Unknown) 2/9/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor58 Not In Scope OUS Quebec City, Canada Toxicokinetics GLP Requalification None Q2 MM (Unknown) (Unknown) (Unknown) 2/9/17 (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor59 In Progress OUS Assen, New Zealand Bioanalytical GLP Requalification/Q On Site Q2 MM OG AK (Unknown) 2/9/17 (Unknown) (Unknown) 6/29/17 9/19/17 9/21/17 10/21/17 (Unknown) (Unknown)
Vendor60 Scheduled USA Sterling, VA Archival Services GLP Requalification On Site Q3 MM RD AA (Unknown) 2/9/17 (Unknown) (Unknown) 6/16/17 11/15/17 11/16/17 12/16/17 (Unknown) (Unknown)
Vendor61 Scheduled USA Sterling, VA Pathology services GLP Requalification On Site Q3 MM (Unknown) AA (Unknown) 2/9/17 (Unknown) (Unknown) 6/16/17 11/14/17 11/14/17 12/14/17 (Unknown) (Unknown)
Vendor62 Scheduled USA Middleton, WI Bioanalytical GLP Requalification On Site Q3 MM RD CL (Unknown) 2/9/17 (Unknown) (Unknown) 6/29/17 11/29/17 12/1/17 12/31/17 (Unknown) (Unknown)
Vendor63 Scheduled USA Ithaca, NY Bioanalytical GLP Requalification/Q On Site Q4 MM (Unknown) BM (Unknown) 2/9/17 (Unknown) (Unknown) 9/15/17 11/14/17 11/15/17 12/15/17 (Unknown) (Unknown)
Vendor64 In Progress USA East Millstone, NJ Toxicokinetics Bioanalysis General Toxicology Inhalation Analytical Carcinogenicity Safety Pharmacology Reproductive Toxicology GLP Requalification/Q On Site Q4 MM MM and KD AA (Unknown) 2/9/17 (Unknown) (Unknown) 8/31/17 10/3/17 10/5/17 11/4/17 (Unknown) (Unknown)
Vendor65 Closed USA Salt Lake City, UT Data Transfer, Activity Testing & Sequencing Assay GCP Qualification On Site Q1 JMD MR DF 23141 2/24/17 (Unknown) (Unknown) 3/17/17 4/19/17 4/20/17 5/20/17 5/19/17 On-time
Vendor66 Closed USA Valencia, CA San Jaun Capistrano, CA Antigen Receptor Assay, Data transfer and Sample Receipt/management, and expiry GCP Requalification On Site Q2 JMD JM DF 23237 4/14/17 (Unknown) (Unknown) 4/14/17 5/23/17 5/24/17 6/23/17 6/22/17 On-time
Vendor67 Not In Scope USA Baltimore, MD Biopsy Sample Kits & Sample Analysis GLP Qualification On Site *CSQA did not participate Q2 MM MR see notes (Unknown) 4/14/17 (Unknown) (Unknown) 4/14/17 5/1/17 5/2/17 6/1/17 5/25/17 On-time
Vendor68 In Progress OUS Neuland, Switzerland Raw Material Mfg., Starting Matertial Mfg., DS Intermediate and/or DS Mfg., Analytical Services, Microbiology Services, Stability Testing Services, Packaging & Labeling Mfg., Warehouse & Distribution GMP Qualification Questionnaire Q2 GN JR WS 22664 4/21/17 5/4/17 5/19/17 5/4/17 5/24/17 5/24/17 6/23/17 (Unknown) (Unknown)
Vendor69 Closed OUS Groningen, New Zealand SDTM GCP Requalification Remote Q1 JMD SK AK 23178 3/8/17 (Unknown) (Unknown) 3/6/17 3/6/17 3/6/17 4/5/17 4/5/17 On-time
Vendor70 Not In Scope OUS Sydney, Australia (Unknown) GCP (Unknown) (Unknown) (Unknown) JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor71 Not In Scope USA Columbia, MD (Unknown) GCP (Unknown) (Unknown) (Unknown) JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor72 Not In Scope OUS Paris, France (Unknown) GCP (Unknown) None (Unknown) JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor73 Not In Scope OUS Dublin, Ireland (Unknown) GCP (Unknown) None (Unknown) JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor74 Pending USA Cincinati, OH (Unknown) GCP (Unknown) TBD (Unknown) JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor75 Not In Scope USA Madison, WI Phase 1 Clinical Research Unit GCP Requalification None Q3 MJ MJ (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) 7/11/17 7/13/17 8/12/17 8/16/17 Delayed
Vendor76 Closed USA Bluebell, PA Model GCP Requalification On Site Q3 JMD MS BM (Unknown) (Unknown) (Unknown) (Unknown) 7/18/17 8/9/17 8/10/17 9/9/17 9/7/17 On-time
Vendor77 Cancelled USA Moorestown, NJ Packaging & Labeling Mfg., Warehouse & Distribution GMP Qualification None Q3 GN (Unknown) BM (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor78 Completed OUS Kaiseraugst, Switzerland Method setup, method validation/co-validation, and method transfer, analytical testing for release and stability - for DP & DS GMP Qualification On Site Q3 GN ZP DF 23615 (Unknown) (Unknown) (Unknown) 6/30/17 8/8/17 8/9/17 9/8/17 9/8/17 On-time
Vendor79 Closed USA Princeton, NJ electronic systems GCP Requalification Remote Q3 MJ (Unknown) DF 23605 (Unknown) (Unknown) (Unknown) 8/2/17 8/22/17 8/23/17 9/22/17 9/25/17 Delayed
Vendor80 Pending OUS Nottingham, United Kingdom (Unknown) GCP Qualification On Site Q3 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor81 Not In Scope USA Raliegh,NC (Unknown) GCP Qualification None Q3 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor82 In Progress OUS Lisbon, Portugal Warehouse & Distribution GMP Qualification On Site Q3 GN Vendor3 WS (Unknown) 8/3/17 (Unknown) (Unknown) 9/8/17 9/25/17 9/26/17 10/26/17 (Unknown) (Unknown)
Vendor83 Not In Scope USA Cambridge, MA (Unknown) GCP Qualification None Q3 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor84 Not In Scope USA Durham, NC (Unknown) GCP Requalification None Q3 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor85 Not In Scope USA Woburn, MA (Unknown) GCP Qualification None Q3 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor86 Scheduled USA Rochester, NY Services for clinical trials, Project Management, Core Lab Services, Equipment Management GCP Requalification On Site Q3 - Q4 JMD KC TBD (Unknown) (Unknown) (Unknown) (Unknown) 9/7/17 11/1/17 11/2/17 12/2/17 (Unknown) (Unknown)
Vendor87 Pending USA Bethesda MD (Unknown) GCP Requalification On Site Q3 - Q4 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor88 Scheduled OUS Fibtaine-les-Dijon, France (Unknown) GCP Requalification On Site Q3 - Q4 JMD CH TBD (Unknown) (Unknown) (Unknown) (Unknown) 9/7/17 11/13/17 11/14/17 12/14/17 (Unknown) (Unknown)
Vendor89 Pending OUS North Wales, Australia (Unknown) GCP Requalification On Site Q4 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor90 Pending USA Los Angeles, CA (Unknown) GCP Requalification On Site Q4 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor91 Pending OUS Singapore, Singapore (Unknown) GCP Requalification On Site Q4 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor92 Pending OUS Dublin, Ireland (Unknown) GCP Requalification On Site Q4 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor93 Not In Scope USA Puyallup, WA (Unknown) GCP Requalification None Q4 JMD (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown) (Unknown)
Vendor94 In Progress USA Middleton, WI Analytical Services & Stability Testing Services for clinical and commercial (GMP) GMP Qualification On Site Q4 GN RN PW 23616 (Unknown) (Unknown) (Unknown) (Unknown) 8/31/17 8/31/17 9/30/17 (Unknown) (Unknown)
Vendor95 Scheduled OUS Leiden, Netherlands Serve as CRU for phase 1 Study GCP Qualification On Site Q3 MJ (Unknown) SK (Unknown) (Unknown) (Unknown) (Unknown) 8/21/17 11/13/17 11/14/17 12/14/17 (Unknown) (Unknown)
Vendor96 Cancelled USA NJ/Los Angeles (Unknown) (Unknown) GCP Requalification None Q3 JMD MS TBD (Unknown) (Unknown) (Unknown) (Unknown) 9/7/17 11/14/17 11/15/17 12/15/17 (Unknown) (Unknown)