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PharmAdhoc - Pharmadhoc

Coding consulting

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PharmAdhoc - Pharmadhoc | pharmadhoc.com Reviews
<META>
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Coding consulting
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1 MedDRA
2 Coding
3 NCI CTC
4 WHO DRUG
5 UMC
6 Coding tool
7 Oncology
8 CRO
9
10 coupons
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pharmadhoc,pharmadhoc com,coding tools,documentation,nci ctc,services,coding guidelines
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PharmAdhoc - Pharmadhoc | pharmadhoc.com Reviews

https://pharmadhoc.com

Coding consulting

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1

Coding tools - PharmAdhoc

http://www.pharmadhoc.com/coding-tools.html

The FDA has adopted the MedDRA dictionary for coding the adverse event data stored in the FDA adverse events reporting system database and Manufactures are encouraged to comply with the FDA requirements. In the next years, all expedited (serious) adverse drug reaction reports will be submitted electronically to major global regulatory agencies ( FDA. Bull; Manage MedDRA dictionary updates and all other dictionaries. Bull; Browse the MedDRA content. Bull; Provide patients and sites information. 8 eClinica...

2

Documentation - PharmAdhoc

http://www.pharmadhoc.com/documentation.html

Pharmaceutical manufactures are encouraged to set up coding rules and guidelines when using medical terminologies. This is particularly recommended for the MedDRA dictionary. A guidelines document “points to consider” was created to help pharmaceutical manufacturers, clinical investigators and other users achieve consistency in the manner in which they assign terms when using MedDRA. It is currently available for comment through the MedDRA Maintenance and Support. Adverse Drug Reaction Dictionaries.

3

NCI CTC - PharmAdhoc

http://www.pharmadhoc.com/nci-ctc.html

The National Cancer Institute's (NCI). The Common Toxicity Criteria (CTC). The Common Toxicity Criteria is a standard language for reporting adverse events occurring in cancer clinical trials. The National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) developed the original CTC in 1982. The CTC was revised in 1998 in order to promote accuracy and precision of reporting, and to avoid development of non-standard adverse event nomenclature or inconsistent definitions for severity. CTCAE ...

4

Services - PharmAdhoc

http://www.pharmadhoc.com/services.html

MedDRA use, coding outsourcing, on-site coding, and legacy data conversion. Establishing of a conceptual synonym table. Development of coding guidelines. Coding and dictionary training for coders, data managers, Clinical Investigators, study coordinators, CRAs, information technology specialists, and other members associated with the implementation and maintenance of coding dictionaries. Reviewing codes and ensuring coding consistency. Assistance on improving coding tools. The JKL Medical Dictionary.

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