Projects
ThesIS has an outstanding record for completing projects on-time and within budget. We are especially adept at meeting challenging timelines while still maintaining our high standards for quality. Our clients call upon us in emergency situations because they know they can count on us to provide extremely quick turnaround even on short notice. Whether your project is small or large, you will receive the same careful attention to detail and personalized service that we give all our clients.

ThesIS has completed projects ranging from just a handful of terms to datasets with more than 200,000 unique terms. Below are some examples of projects we have completed. These projects are in addition to the ongoing coding of clinical trials and drug safety we provide for clients who outsource all their coding to us. Please contact us if you would like more information about any of the projects listed.

Coding Projects
Versioning Projects
Training Projects
Consulting Projects

Coding Projects

  • Emergency coding of 3,800 surgical procedures and medical history terms to ICD-9 (October 2001 version) for a large CRO

  • Coding of 2,500 legacy adverse event (AE) terms to MedDRA 5.1 for a medium pharma company

  • Expedited coding of 211,000 legacy AE terms to MedDRA 7.0 for a drug safety conversion project for a large pharma company

  • Emergency coding of 2,800 drug terms to WHO Drug Format C (Q4 2003 version) for a medium size pharma company needing immediate turnaround with no advance notice in order to complete a key clinical trial for an imminent NDA filing

  • Coding of 10 clinical trials for the subsidiary of a large pharma company
    • 1,000 AE terms to MedDRA 6.0
    • 160 AE terms to MedDRA 7.0
    • 1,900 AE terms to MedDRA 9.0
    • 2,400 concomitant medications to WHO Drug Format C (Q3 2004)

  • Coding of 1,200 AEs from four clinical trials to MedDRA 8.0 for a small biopharm company

  • Coding of a clinical trial for a small CRO
    • 1,200 AE, physical exam, and medical history terms to MedDRA 9.0
    • 900 concomitant medications to WHO Drug Format C (March 2006 version)

  • Expedited coding of 1,200 indication terms to ICD-9-CM (2006) for a large biotech company

  • Overflow coding for a large biotech company to bridge a temporary staffing deficiency
    • 700 AE terms to MedDRA 9.0
    • 350 concomitant medications to WHO Drug Format B2 (Q4 2003)
    • 900 concomitant medications to WHO Drug Format B2 (March 2006)

  • Expedited coding for a large pharma company
    • 20,000 legacy AE terms to MedDRA 9.1
    • 29,000 legacy AE terms to MedDRA 9.1

  • Immediate coding of 75 serious AE terms to MedDRA 9.1 for a medium pharma company

  • Extremely urgent coding of 7,000 legacy AE terms to MedDRA 9.1 for a large pharma company

  • Coding for a small pharma company
    • 80 AE terms to MedDRA 9.1
    • 50 concomitant medications to WHO Drug Format B2 (December 2006 version)

  • Coding of 4,000 legacy AE terms to MedDRA 9.1 for a medium pharma company

  • Coding of 500 AE terms to MedDRA 10.0 for a small CRO

  • Coding of 500 concomitant medications to WHO Drug Format C (March 2007 version) for a small pharma company

  • Coding of 13 studies for a small CRO
    • 235 AE terms to MedDRA 6.1
    • 420 AE terms to MedDRA 10.0
    • 320 concomitant medications to WHO Drug Format C (March 2007 version)

  • Extremely urgent coding of 250 AE terms to MedDRA 10.0 for a large CRO

  • Expedited coding of 300 AE terms to MedDRA 10.0 for a medical device company

  • Coding for a small biotech company
    • 450 AE terms to MedDRA 10.1
    • 200 concomitant medication terms to WHO Drug Format C (September 2007 version)

  • Coding for a medium biotech company
    • 5,000 legacy AE, medical history, and death terms to MedDRA 10.1
    • 3,000 legacy concomitant and prior medication terms to WHO Drug Format C (September 2007 version)

  • Coding of 110,000 AE terms to MedDRA 10.1 to create a synonym list for the pharmacoviligance group of a large pharma company

  • Coding of three clinical trials for a medium biotech company
    • 1,200 AE, medical history, and death terms to MedDRA 10.1
    • 600 concomitant and prior medication terms to WHO Drug Format C (September 2007 version)

  • Emergency coding of 325 concomitant medication terms to WHO Drug Format C (Q4 2003 version) for a small CRO

  • Coding of 500 concomitant medication terms to WHO Drug Format C (March 2008 version) for a small CRO

  • Coding for a medium biotech company
    • 300 AE, medical history, and death terms to MedDRA 11.0
    • 350 concomitant and prior medication terms to WHO Drug Format C (March 2008 version)

  • Coding of 9,000 indication terms to a custom indications dictionary for a medium biotech company

  • Coding of legacy data for a medium biopharm company
    • 1,450 AE terms to MedDRA 12.0
    • 1,600 concomitant and prior medication terms to WHO Drug Format C (March 2009 version)

  • Coding of 6,500 AE terms to MedDRA 12.0 for a large CRO

  • Expedited coding for a medium pharma company
    • 700 AE terms to MedDRA 12.1
    • 635 concomitant medication terms to WHO Drug Format C (September 2009 version)

  • Coding of 18,000 medical history terms to MedDRA 12.1 for a medium pharma company

  • Coding of eight legacy studies for a medium biopharm company
    • 500 AE terms to MedDRA 13.0
    • 730 concomitant medication terms to WHO Drug Format C (March 2010 version)

Versioning Projects

  • Versioning for a small biotech company
    • 220 AE terms from MedDRA 6.0 and 6.1 to MedDRA 7.0
    • 5,100 AE terms from MedDRA 6.1 to MedDRA 8.0
    • 300 AE terms from MedDRA 7.0 to MedDRA 8.0

  • Versioning of 100 SAE terms from MedDRA 7.1 to 8.1 for the drug safety department of a medium biotech company

  • Versioning of clinical trials for a medium biotech company
    • 700 AE terms from MedDRA 7.1 to MedDRA 8.1
    • 300 AE terms from MedDRA 8.1 to MedDRA 9.0
    • 450 AE terms from MedDRA 9.0 to MedDRA 10.0
    • 9,200 AE terms from MedDRA 10.0 to MedDRA 10.1
    • 8,400 AE terms from MedDRA 10.1 to MedDRA 11.0
    • 7,650 AE terms from MedDRA 11.0 to MedDRA 11.1
    • 2,450 AE terms from MedDRA 11.1 to MedDRA 12.0
    • 3,600 AE terms from MedDRA 12.0 to MedDRA 12.1

  • Versioning of 20,000 medication terms from WHO Drug Format C (Q3 2004) to WHO Drug Format C (March 2006) for a small biotech company

  • Versioning of 2,000 concomitant medication terms from WHO Drug (September 2007) to WHO Drug (March 2008) for a medium biotech company

  • Versioning for a medium biotech company
    • 6,000 AE terms from MedDRA 10.1 to MedDRA 11.0
    • 3,300 concomitant medication terms from WHO Drug (September 2007) to WHO Drug (March 2008)0

  • Versioning of 7,400 AE terms from MedDRA 10.0 and MedDRA 10.1 to MedDRA 11.0 for a large pharma company

  • Versioning of 630 AE terms from MedDRA 12.0 to MedDRA 12.1 for a small biotech company

  • Versioning for a large CRO
    • 700 AE terms from MedDRA 12.0 to MedDRA 12.1
    • 2,500 AE terms from MedDRA 12.1 to MedDRA 13.0
    • 1,650 CM terms from WHO Drug (March 2009) to WHO Drug (September 2009)
    • 5,000 CM terms from WHO Drug (September 2009) to WHO Drug (March 2010)

  • Versioning of 21,000 AE and SAE terms from MedDRA 12.0 to MedDRA 13.0 for a large CRO

  • Versioning for a large pharma company
    • 22,000 AE and MH terms from MedDRA 11.0 to MedDRA 11.1
    • 30,000 AE and MH terms from MedDRA 11.1 to MedDRA 12.0
    • 37,000 AE and MH terms from MedDRA 12.0 to MedDRA 12.1
    • 43,000 AE and MH terms from MedDRA 12.1 to MedDRA 13.0

Training Projects

  • Customized MedDRA training for a medium size pharma company

  • MedDRA training for the drug safety department of a small pharma company

  • WHO Drug training for a medium size pharma company

  • WHO Drug training for the data management and drug safety departments of a medium size pharma company in preparation for a company-wide WHO Drug implementation

  • Introductory MedDRA and WHO Drug training to the data management department of a small pharma company
    • Introduction to MedDRA
    • Introduction to WHO Drug

  • One-on-one WHO Drug training for the in-house coder at a large CRO

  • Introductory MedDRA and WHO Drug training to the data management and regulatory affairs departments of a small pharma company
    • Introduction to MedDRA
    • Introduction to WHO Drug

  • Customized MedDRA training to the clinical research staff of a medium CRO
    • Introduction to MedDRA
    • Prerequisites for MedDRA Coding
    • Advanced MedDRA Coding

  • Customized, intermediate-level WHO Drug and MedDRA training to the medical affairs staff of a medium CRO
    • Intermediate WHO Drug Coding
    • Intermediate MedDRA Coding

  • MedDRA and WHO Drug training to the data management department of a small biotech company
    • MedDRA Coding
    • Introduction to WHO Drug
    • WHO Drug Coding

Consulting Projects

  • Weekly quality assurance reviews (over a six-month period) of serious adverse event terms coded to MedDRA 5.1 by a large pharma company's in-house staff

  • Complete implementation of MedDRA for the drug safety department of small pharma company, including:
    • Creation of company-specific MedDRA coding conventions
    • MedDRA training for the company's Drug Safety Associates
    • Coding of legacy SAE terms to MedDRA 6.0
    • Information technology support for modifications to vendor-supplied drug safety system to accommodate MedDRA
    • Versioning of SAE terms from MedDRA 6.0 to MedDRA 6.1

  • Computer systems validation of an Oracle Clinical Thesaurus Management System (TMS) installation for a large biotech company

  • Conversion of safety data from a legacy drug safety system into the Relsys Argus safety system for a small biopharm company
    • Migration of serious adverse event reports from the legacy system to Argus
    • Coding of COSTART terms to MedDRA
    • Education of drug safety staff in the use of MedDRA

  • Guidance, strategy, and recommendations for a WHO Drug implementation for a small biotech company

  • Quality assurance review of CRO-coded data for a large pharma company
    • 10,300 AE and medical history terms coded to MedDRA 11.0
    • 8,600 concomitant medication terms coded to a sponsor-customized WHO Drug dictionary (Format B2, Q3 2005 version)

  • Quality assurance review of six studies coded by multiple CROs for a medium pharma company
    • 15,000 AE and SAE terms coded to MedDRA 11.0
    • 12,000 concomitant medication terms coded to WHO Drug Enhanced, Format B2 (March 2008 version)

  • Quality assurance review of 15,000 AE terms coded to MedDRA 12.0 for a large CRO

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