Publications from Clinical Device Group…

Web Publications

Nancy J Stark CV

 Nancy J Stark Biosketch

 

Michelle Secic and Nancy J Stark, "What's Special about Diagnostic Trials?" CDG eConference Series, 6 Mar 07.

 

Nancy J Stark, “Designing Paper-Based Case Report Forms” CDG eConference Series, 8 Mar 07.
 

Ken Schiff and Nancy J Stark, “ISO or ICH—Which One for You?” FOI Services audio-conference, 30 Aug 06.

Nancy J Stark, "Starting in Europe", July 2004

Nancy J Stark, “What’s Up with Monitoring and the FDA?”, June 2004.

Nancy J Stark, “Clinical Databases and Part 11: The Regulated Database”, FOI Online, 27 June 2004.

Nancy J Stark, “Quality Systems for Clinical Research”, CDG eConference Series, May 2006.

Nancy J Stark, "Survey of Clinical Research Practices in the Medical Device Industry", Jan, 2004 Here is the update to our annual survey of clinical research practices in the medical device industry. We've included trend analyses on the number of IDEs, studies for 510k support, studies for CE Mark, adverse event reporting, most popular host countries, studies per monitor, and other benchmarks. Data presentation compares US, EU, the implant sector, and new this year, the disposables sector.

Nancy J Stark, "Clinical Databases and Part 11: Designing Case Report Forms", 5 Sep, 2003. Case report form design isn't difficult if you follow a few simple rules. This presentation gives you strategy and tactics for designing case report forms that collect meaningful data in a user friendly way.

Nancy J Stark, "ISO/FDSI 10993-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity - A Manager's Quiz", July 15, 2003 . Test your knowledge on medical device Genotoxicity by taking this clever quiz.

Nancy J Stark, “Clinical Databases and Part 11: A Beginner’s Walk through Part 11”, May 2, 2003. Part 11 is sweeping in its scope, covering the entire computerized system, including the hardware, software, cabling, email and web communications, installation, configuration, maintenance, documentation, training, SOPs, back-up and recovery, disaster recovery, physical security, environmental security, and any other element that can contribute to or affect clinical databases. This beginner’s walk reduces a complex regulation to a garden stroll, telling you how to apply Part 11 to your clinical study.

Nancy J Stark, “Clinical Databases and Part 11: The Regulated Database”, FOI Online, April 24, 2003.

Nancy J Stark, "Survey of Clinical Research Practices in the Medical Device Industry", Jan 2002.

Nancy J Stark, "HIPPA--Security and Privacy Impact on Clinical Research", July, 2002. While not directly regulated by HIPAA, sponsors face a unique set of problems when they initiate clinical research. Only sites are covered entities, subject to HIPAA control. But sponsors may want to make changes to informed consents, write separate authorizations, or obtain waivers from IRBs, in order to monitor and possess data. Some sites ask sponsors to become business associates, especially when tracking rules apply. Here are some strategies to assure continued access to your data.

 Nancy J Stark, "ISO 10993--Biological Evaluation of Medical Devices: A Manager's Quiz", May 28, 2002.

Nancy J Stark, "Predicting the Future: Clinical Research in the US", March 22, 2002.

Nancy J Stark, "Declaration of Helsinki - Controversies with Revisions 2000", Oct 31, 2001. 

Nancy J Stark, "Survey of Clinical Research Practices in the Medical Device Industry", Aug 18, 2001

 

 

 

Articles
 
Nancy J Stark, "Outsourcing Clinical Research: A Comparison between the US and the EU" Regulatory Affairs Journal, Devices (2004) Jan/Feb: 13

Nancy J Stark, "A Long Road: 25 Years of Clinical Research" Medical Device & Diagnostic Industry, (2004) August:96

Nancy J Stark, “Clinical Outsourcing in Europe”, Medical Products Outsourcing, (2004) June: 64.

Nancy J Stark, "Clinical Studies: Europe or the United States?", (2004) Medical Device & Diagnostic Industry, May:134

Nancy J Stark, “Understanding Biological Safety”, Medical Device Technology, September, (2002) Volume 13(7): 28.

Nancy J Stark, "Manager's Series: Biological Evaluations of Medical Devices--Part 1, Evaluation", (2002), MedSpark, July 02.

Nancy J Stark, "HIPPA & EU data protection--the dos and dont's of privacy", (2002) Clinica, June 5:1010.

Nancy J Stark, "Meeting the Requirements of the Personal Data Protection Directive Through HIPAA Privacy Rules", (2001), MedSpark, Dec:1.

Nancy J Stark, and Heath, E, "Incorporating the New HIPAA Privacy Rules into Medical Device Trials", (2001), Medical Device & Diagnostic Industry, July:114.

Nancy J Stark, "Clinical Research in the Product Development Cycle", (2001) Medical Device & Diagnostic Industry, May:150.

Nancy J Stark, "Prufzentren - Management bei klinischen Studien" (2000) Deutsche Zeitschrift fur Klinische Forschung, August:29.

Nancy J Stark, "Clinical Trials for Medical Devices, Information for Investigators" (2000) The Monitor, Volume 14:1, Spring.

Nancy J Stark, Rasmussen P, Spencer H, "Clinical Trial Site Management" (1999) Global CONTACT, Number 21:31.

Nancy J Stark, "Managing Adverse Events and Effects during Clinical Trials"(1999) Medical Device & Diagnostic Industry, July:88.

Nancy J Stark, "Conducting Health-Based Risk Assessments of Medical Materials"(1998) Medical Plastics and Biomaterials, September/October, 5(5):18.

Nancy J Stark, "Requirements for Clinical Trials for Medical Devices" (1997) Technology News, American Medical Association, April:1.

Nancy J Stark, "Using Data Obtained Overseas for FDA Approval" (1997) Applied Clinical Trials, September:38.

Nancy J Stark., "Software Can Help Manage Clinical Trials" (1997) Medical Device & Diagnostic Industry, April.

Nancy J Stark, "The Clinical Research Industry: New Options for Medical Device Manufacturers" (1997) Medical Device & Diagnostic Industry, January:215.

Nancy J Stark, "Clinical Trials for Medical Devices, An Introduction"(1997) Applied Clinical Trials, January:34.

Stark NJ, "Clinical Research for CEOs: A Guide to Good Business Practice and the Conduct of Clinical Trials" (1996) Clinica, 736/737:17.

Nancy J Stark, "The Biological Safety of Nitinol: A Case Study in New Material Evaluation" (1996) The Validation Consultant, 3(9):8.

Nancy J Stark, "Managing Positive Biocompatibility Test Results", (1996) Medical Device & Diagnostic Industry, 18(10):148.

Nancy J Stark, "Introduction to Monitoring", (1996) Applied Clinical Trials, 5(5):34-40.

Nancy J Stark, "Literature Report: Biological Safety of Parylene C", (1996) Medical Plastics and Biomaterials, 3(2): 30.

Nancy J Stark, "Designing Clinical Trials for Business and Marketing Needs", (1995) The Booth Validator, 2(1): 3.

Nancy J Stark, "Documenting Test Material Characterization", (1994) Medical Plastics and Biomaterials, 1(2): 50-55.

Nancy J Stark, "Biocompatibility Management: A Quality System for Biological Safety", (1994) Medical Device & Diagnostic Industry, 16(3):92-100.

Nancy J Stark, "Standard Operating Procedures and Biological Safety Testing", (1994) Medical Device & Diagnostic Industry, 16(5):238-242.

Nancy J Stark, "How to Reorganize a Clinical Research Department", (1992) Medical Device & Diagnostic Industry, 14(6):154-159.

Nancy J Stark, "A Chemist's View of Biocompatibility", (1991) Medical Device & Diagnostic Industry, 13(5):86-93.

Nancy J Stark, "How to Organize a Biocompatibility Testing Program: A Case Study", (1991) Medical Device & Diagnostic Industry, 13(6):68-75.

Nancy J Stark, "A Context for Clinical Research" (guest editorial), (1986) Medical Device & Diagnostic Industry, 8:10.

 

 

Books

 
Nancy J Stark, Clinical Trials Design: Evaluation for Medical Devices, Second Edition (2002), Scientist Sha, Tokyo,  Japan. (Translation into Japanese arranged by Japan Uni Agency, Tokyo, Japan, 2004).

Nancy J Stark, Biocompatibility Testing & Management, (1996, 1998, 2003), Clinical Device Group Inc, Chicago, IL.

Nancy J Stark, Clinical Trials Design (1996, 2000) Clinical Device Group Inc, Chicago, IL.

Nancy J Stark, Project Management, (1999, 2003), Clinical Device Group Inc, Chicago, IL.

Nancy J Stark, Applied Regulations, (2002, 2004) Clinical Device Group Inc, Chicago, IL.

Nancy J Stark, Good Monitoring Practices (1996, 2004) Clinical Device Group Inc, Chicago, IL.

Nancy J Stark, CRA Handbook (1995, 1998, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007) Clinical Device Group Inc, Chicago, IL.

Nancy J Stark, Investigator's Guide to Clinical Research (2002)

Nancy J Stark, Investigator Handbook: On-Site Organization and Management (1997) Clinical Device Group Inc, Chicago,   IL.

Nancy J Stark, Editor, Europe Laws, (2002, 2005) Clinical Device Group Inc, Chicago, IL.

Nancy J Stark, Editor, US Guidances for Clinical Research (2002, 2005)

Nancy J Stark, International Clinical Trials, (1996, 1998) Clinical Device Group Inc, Chicago, IL.

 

 

Presentations

 
Nancy J Stark, "Medical Device Adverse Events", Global ACRP Meeting, Seattle, WA, 22 April 07.

Nancy J Stark, “From Claims to Protocols”, Regional RAPS Meeting, Chicago, IL, 29 Sept 05.

Nancy J Stark, “Project Management for Medical Device Trials”, two-day training at MedicoIndustrien, Copenhagen, Denmark, 15-16 Sept 05.

Nancy J Stark, “Biocompatibility Testing & Management”, two-day training at MedicoIndustrien, Copenhagen, Denmark, 13-14 Sept 05.

Nancy J Stark, "From Claims to Clinicals: How claims Set the Specifications for Your Protocol", 2nd Meeting of Japan Forum of Clinical Trials on Medical Devices, 3 Sept 05, Tokyo Japan.

Nancy J Stark, “European Medical Device Regulation”, three-day training at FDA/CDRH, Washington, DC. 13-15 July 05.

 

Nancy J Stark, "A Comparison of ISO 14155 and ICH-GCPs", Barnett/Paraxel Summit on Drug and Device Safety, 4 May 05, Philadelphia, MD

 

Nancy J Stark, "Data Management for Medical Devices: Confusion and Controversy" DIA Data Management Conference, 9 Nov 04, Amsterdam, The Netherlands.

Nancy J Stark, “Device Clinical Trials in the European Union”, FDA/CDRH College, 27 April 04, Rockville, MD.

Nancy J Stark, “Clinical Research Practices in the Device Industry,” Center for Business Intelligence conference on Pre-clinical and Clinical Trials for Medical Device and Combination Products, 11-12 March 04, Minneapolis, MN.

Nancy J Stark, “Regulated Databases: Navigating Computerized Systems Used in Clinical Trials”, Center for Business Intelligence conference on Pre-clinical and Clinical Trials for Medical Device and Combination Products, 11-12 March 04, Minneapolis, MN.

Nancy J Stark, “Project Management for Clinical Research,” ASQ New England, 18 Nov 03, Needham, MA.

Nancy J Stark, Keynote Address: “Clinical Research Practices in the Device Industry”, ASQ New England, 18 Nov 03, Needham, MA.

Nancy J Stark, “Basic Aspects and Principal Problems in the Management of a Clinical Study”, DIA Second Latin American Congress of Clinical Research, 29 Sep-1 Oct 03, Mexico City, Mexico.

Nancy J Stark, “Clinical Databases and Part 11: The Regulated Database”, Orange County Regulatory Affairs Society, 4-5 June 03, Irvine, CA.

Nancy J Stark, “Clinical Databases and Part 11: A Layman’s Primer to System Documentation”, DIA Device Conference, 24-25 Feb 03, San Francisco, CA.

Nancy J Stark, "Closing Plenary--Predicting the Future of Clinical Research: New Government Initiatives that Impact Clinical Trials", RAPS Clinical Trials Conference, August 5-6, 2002, Washington DC.

Nancy J Stark, "HIPPA Requirements and Their Effect on Clinical Research", RAPS Clinical Trials Conference. August 5-6, 2002, Washington, DC.

Nancy J Stark, "Predicting the Future: Clinical Research in the United States", SoCRA, Minnesota Local Chapter, June 13, 2002, Minneapolis, MN.

Nancy J Stark, "HIPPA--Health Insurance Portability and Accountability Act", SoCRA, Minnesota Local Chapter, June 13, 2002, Minneapolis, MN.

Nancy J Stark, "HIPPA--Health Insurance Portability and Accountability Act", FDA/OCRA Educational Conference, June 3-4, 2002, Irvine, CA.

Nancy J Stark, "Case Study: Dulce Devices Implementing ISO EN 14155-1 & 2", AAMI/FDA International Conference on Medical Device Standards and Regulation, March 27-28, 2002, McLean, Virginia.

Nancy J Stark, "Current US Regulatory and Ethical Issues in Clinical Research", Regulatory Affairs Professionals Society, March 20, 2002, San Francisco, CA.

Nancy J Stark, "Investigator Selection & Clinical Study Monitoring", Medical Alley, March 13-20, 2002, St. Paul, MN.

Nancy J Stark, "Survey of Clinical Research Practices: Medical Device Industry", July 18, 2001, St. Paul, MN.

Nancy J Stark, "Current Topics in Clinical Research", Biomedical Focus, July 18, 2001, St. Paul, MN.

Nancy J Stark, “Device Clinical Trials in the European Union”, FDA/CDRH College, 21 June 01, Rockville, MD.

Nancy J Stark, “Current Topics in Clinical Research”, Medical Design & Manufacturing East, 5 June 01, New York, NY.

Nancy J Stark, "Clinical Trials for Medical Devices", Regulatory Affairs Professionals Society, October 2-4, 2000, Washington, DC.

Nancy J Stark, "Managing Subject Risk in Device Trials", Association of Clinical Research Professionals, May 15-17, 2000, New Orleans, LA.

Nancy J Stark, "Project Management: A Case Study," Institute for International Research Conference on Project Management for Research & Development and Clinical Research, February 23-25, 2000, Philadelphia, PA.

Nancy J Stark, "Clinical Trial Site Management", Association of Clinical Research Professionals, April 21-24, 1999, Washington, DC.

Nancy J Stark, "Clinical Trial Site Management", Biomedical Focus, July 20-22, 1998, Minneapolis, MN.

Nancy J Stark, "Working with CROs", Biomedical Focus, July 20-22, 1998, Minneapolis, MN.

Nancy J Stark, "Health-Based Risk Assessments", Biomedical Focus, July 20-22, 1998, Minneapolis, MN.

Nancy J Stark, "Case Studies: Material Safety Reviews", Medical Design & Manufacturing East97, June 1-5, 1997, New York, NY.

Nancy J Stark, "Using Foreign Clinical Data in US Submissions", International Business Communications Conference, August 15-16, 1996, Williamsburg, VA.

Nancy J Stark, "Managing Positive Biological Safety Result", Biomedical Focus X, July 15-17, 1996, Minneapolis, MN.

Nancy J Stark, "The Changing Clinical Research Industry: A Challenge for the Future", Biomedical Focus X, July 15-17, 1996, Minneapolis, MN.

Nancy J Stark, "Managing Positive Biological Safety Results", Medical Design and Manufacturing West, February 6-8, 1996, Anaheim, CA.

Nancy J Stark, "Policies of Quality and Management in Cosmetic Dermatology", International Society of Cosmetic Dermatology, October 26, 1995, Montecatini Terme, Italy.

Nancy J Stark, "Solving Quality Problems in Biocompatibility Management", Session Chair, Medical Design and Manufacturing East, May 24-26, 1994, New York City, NJ.

Nancy J Stark, "Identity Documentation for Materials", Medical Design and Manufacturing East, May 24-26, 1994, New York City, NJ.

Nancy J Stark, "Materials and Surveillance Screening—Why and How", Medical Design and Manufacturing East, May 25-27, 1993, New York City, NY.

Nancy J Stark, "Biological Safety: Design and Planning Issues", Biomedical Focus VI Conference and Exposition, July 27-29, 1992, Bloomington, MN.

Nancy J Stark, "Materials Screening—Why and How", Medical Design and Manufacturing West, February 4-6, 1992, Anaheim, CA.

 
Related topics: biocompatibility, biological safety, immunochemistry, rasH2, transgenic mouse, carcinogenicity, chonic toxicity, ISO 10993, reproductive toxicity, risk assessment, risk analysis, toxicology, toxicologist, AAMI, TAG 194, safety test, biosafety, statistics, sample size, biostatistics, equivalence, equivalent, better than, claim, performance, safety, efficacy, blackwelder, statistical plan, database design, data entry, double, Part 11, hypothesis, ISO 14155, EN 540, project management, sponsor, protocol, literature, investigator brochure, Cochrane Library, research, study, trial, studies, response variable, endpoint, case report form, investigator, site, center, technical writer, FDA, CDRH, 510k, 510(k), premarket notification, , IDE, investigational device exemption, PMA, premarket approval, submission, approval, biomedical, corporate inteligence, medical market, corporate spy, SCIP, competitive inteligence.Nancy J Stark

This page was last updated on 03/27/08