Software
Independent Review of Pharmaceutical Software
Please find below our listing of possible software solutions for the Pharmaceutical, Medical Device or Life Sciences Industry wishing to comply with the FDA, TGA, MHRA regulations.
Clinical Trials Software:
| Vendor | Claim | Website |
| Clintrial, Connect, Clintrial, Clintrace, Integrated Review, Review | Clinsoft Corporation is the world's largest provider of clinical research systems. Clinsoft's information platform enables companies to focus development resources on product "winners" sooner and has brought more pharmaceutical products to market than any other software platform. | www.clinsoft.com |
| TrialXS/EDC | TrialXS / EDC complies with FDA 21 CFR Part 11 regulation and conforms to GCP guidelines. | www.clinsource.com |
| CRF Box wireless | KEY FEATURES OF CRF BOX WIRELESS™: Patient-generated data entry via a wireless or handheld device, Edit checks to diary data before entry into trial database, 2-way communication between clinical R&D stakeholders, Diary page amendments during the trial, Multiple languages and technology platforms in the same trial Flexible generation of reminders and alerts to patients, 21 CFR Part 11 compliance. | www.crfbox.com |
| DataTrak EDC | CFR21;Part 11 Compliant. When you compare EDC product you'll find DATATRAK's Audit Trail to be the best of breed. DATATRAK EDC gives you an audit trail down to the data field. This also means that if the Investigator loses a communications connection, they do not lose data. | www.datatrak.net |
| DocuStore Repository eNOW | Biotechnology research, discoveries and applications ultimately find their way to public use. Any entity that accepts, maintains or transmits electronic data must comply with a standardized Electronic Data Interchange (EDI) format. | www.ensurelink.com |
| iSuite | etrials offers iSuite, an innovative and powerful data entry system that allows investigators and site administrators to make immediate decisions based on having cleaner data -- faster. Our eCRF form is 21 CFR Part 11 compliant. | www.etrails.com |
| Xtrials | We offer a breakthrough, workgroup management technology that is native XML-based, fully 21 CFR Part 11 compliant, and able to be customized for individual company implementations. The XTrials TM Application Architecture is a fully-scalable clinical data management environment for EDC, Clinical Data Review, CSR Analysis/Verification/Peer review, and electronic Regulatory Submissions production. | www.mymatrixml.com |
| CTMS, Impact, | IMPACT (International Management Package for Administration of Clinical Trials) is a highly flexible, web based, tried and tested CTMS. It caters for all trials, from large multi-national trials to single site, investigator-sponsored protocols. The product provides planning and tracking support for all aspects of a trial and consolidates all the information from various collection points into a single source. | www.perceptive.com |
| InForm Clinitrial Clinitrace | Phase Forward's scalable, reliable solutions suite – which integrates electronic data capture (EDC), clinical data management (CDM), and drug safety monitoring – accelerates clinical productivity and streamlines drug safety monitoring and reporting. | www.phaseforward.com |
| Esendant Clinical Network | PHT's Esendant Clinical Network fully conforms to CDISC standards and is compliant with FDA 21 CFR Part 11. | www.phtcorp.com |
| PRO_IRB | PRO_IRB™ is a Microsoft Access-based Institutional Review Board Software Application providing productivity and compliance assurance tools for managing the Institutional Review Board process. Agenda preparation, records SAE, manage continuing review. Complies and exceeds 21CFRpart11 requirements where applicable. | www.proirb.com |
| SymPro V3/V4 | The Symfo is a portable, one-hand operable, electronic patient diary capable of recording patient data in REAL TIME. This secure data transmission will provide a better follow-up of the patient without making a contact between the patient and the investigator necessary. The system has been developed and is produced according to the strict ISO 9001 procedures. The Symfo is a portable, one-hand operable, electronic patient diary capable of recording patient data in REAL TIME. This secure data transmission will provide a better follow-up of the patient without making a contact between the patient and the investigator necessary. The system has been developed and is produced according to the strict ISO 9001 procedures. The system is FDA Part 11 Compliant. | www.symfo.com |
| adWATCH | All of Winchester Business Systems' products and services comply with the requirements of the FDA's 21 CFR Part 11 for electronic signatures and electronic records using the ComPac software module. | www.wbsnet.com |
| ensur | Web-based quality management systems for FDA and ISO regulated companies. One platform provides document control, change control, complaint handling, investigations, CAPAs, employee training/certification tracking, product specification management, version control, and compliance testing. | www.mysticmsi.com |
The above table lists all the Software identified by PharmOut Information Technology.
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