Digital signature company releases PharmaDoX, a product aimed at solving the paper problem of clinical trials.
Chattanooga, TN -- (SBWIRE) -- 02/25/2015 -- SIGNiX, the leading provider of Independent E-Signatures™, announced today that it has launched PharmaDoX, the pharmaceutical industry's first digital signature service created to relieve paperwork burdens of clinical trials. PharmaDoX makes it easy for sponsors, clinical research organizations (CROs), investigators and patients to sign clinical trial documents online while adhering to FDA regulations. This ready-made solution incorporates the requirements of the FDA's 21 CFR Part 11 rule.
Clinical trials and FDA submissions have always been burdened by complex paper processes that are both inefficient and ineffective at collecting data for trial analysis. Electronic workflows give CROs a traceable, auditable way to adhere to trial protocols. By becoming more efficient, CROs can save millions of dollars on paper, toner, time, personnel, postage, overnight shipping charges and storage for cumbersome paper documents.
One early adopter of PharmaDoX has implemented investigator signatures on protocol signature pages, FDA Form 1572 signatures, financial disclosures, delegation of authority forms, CV signatures and protocol training acknowledgments. This CRO saves 1.2 million dollars annually on courier charges alone. Additionally, the CRO has reduced study startup times, nearly eliminated document re-routing and has increased investigator satisfaction by adopting PharmaDoX.
SIGNiX worked closely with the life sciences community to develop PharmaDoX to meet the needs of sponsors and investigators. Complying with 21 CFR Part 11 requires specialized workflows with additional security around the authentication and signing processes that few e-signature solutions can meet. PharmaDoX incorporates all of the compliance protocols behind the scenes, making sure every signature is compliant without any extra effort for signers.
SIGNiX is unique in the electronic signature industry because they offer a cloud-based service that provides Independent E-Signatures™, technology that is based on open, published standards, backed by a fully transparent audit trail and able to be verified independently with no future reliance upon SIGNiX.
SIGNiX, the nation's leading provider of Independent E-Signatures™, makes signing documents online safe and secure. SIGNiX's cloud-based service uses patented technology to give businesses the most secure and legally defensible digital signatures available at a fraction of the cost of paper. SIGNiX's products help the world's leading companies become more efficient, decrease risk and boost profits.
For more information, visit http://www.signix.com