Asides

Case Study 4: A Full Data Management Solution

Working in a Collaborative Environment

The Scenario:

A phase II study was being managed by a CRO that had non-dedicated teams, escalating costs, with project timelines slipping on almost every deliverable.
RA eClinica Solution:

    • RA eClinica assumed responsibility for entire data management activities consisting of Data Management, Study Build / EDC Development, and Statistics and Programming.
    • RA eClinica preferred Data Management systems utilized with Sponsor’s Safety Surveillance system and Clinical Trial Management System, CTMS

Ra eClinica Results:

    • Study ongoing – All deadlines to date have been met or exceeded
    • Cost savings of approximately 35% in comparison to traditional CRO models
    • No turnover since study start

Anayansi Gamboa- Virtual DM Service from RA eClinica

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

Advertisements

Case Study 3: Out-of-Box Solution

The Scenario:

The Sponsor required a solution to effectively manage and control users (internal and external).
RA eClinica Solution:

    • RA eClinica collaborated with the Sponsor to develop and implement a user management system that involved training tracking record (LMS), user access request, Role-based access control
    • Develop, deploy and host the clinical documentation service and provide customer support.

Ra eClinica Results:

    • Development of an electronic tool to manage the program and provide ongoing operational management support..
    • Reports are made accessible based on permission on a web browser CFR-Part 11 compliance is maintained on security and privacy of data.
    • Reports are XML-tagged for further integration with in-house systems and third party service providers,
    • Integrated Help desk support system

Anayansi gamboa - Out of the box solutions by RA eClinica

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

Case Study 2: Supporting the Sponsor with Database Transfer Solution

Assisting the Sponsor with Database Transfer Solution

Anayansi gamboa - Data Management Support @RAeClinica

 

 
The Scenario:

The Sponsor required a large safety and data management team to assist for a submission deadline requiring the transfer of data to a new safety database for clinical trials and post-marketed products.
RA eClinica Solution:

    • RA eClinica responsible for AE/SAE reporting, safety coding, NDA submission support
    • RA eClinica collaborated with the Sponsor’s safety team to develop a functional safety alliance consisting of over 10+ team members inclusive of management, safety and data management resources
    • Ra eClinica team is responsible for managing over 5+ compounds

Ra eClinica Results:

    • RA eClinica project team exceeded the timelines, completing the tasks approximately 30-days ahead of schedule
    • RA eClinica management collaborate with the Sponsor to redefine operational workflow and processes in order to increase efficiencies across several departments (Quality Control, Pharmacovigilance)

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

Case Study 1: Stand Alone Satellite Office Solution

Integrated Into Sponsor’s Clinical Data Management (CDM) Environment

Anayansi gamboa - offshore Panama Data management

 

 

 

 

The Scenario:

The Sponsor was in need of a data management team to function in an integrated manner as an extension of the Sponsor’s CDM team. Based on geographic and offices constraints, coupled with the large volume of work, hiring individual contract resources on-site was not an option.

RA eClinica Solution:

  • RA eClinica Data Management Operations collaborated with Sponsor to develop CDM metrics, collaboration model and workflow, enabling the team to work across 3+ protocols
  • RA eClinica provided a full solution of 5+ CDM resources, project management, dedicated secure facilities integrating into Sponsor’s eClinical and CDMS databases.

Ra eClinica Results:

  • Develop of a long-term, efficient and cost-effective CDM solution.

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

Drug Information Update- FDA approves new drug treatment for nausea and vomiting from chemotherapy

Drug Information Update- FDA approves new drug treatment for nausea and vomiting from chemotherapy
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

Varubi inhibits the CYP2D6 enzyme, which is responsible for metabolizing certain drugs. Varubi is contraindicated with the use of thioridazine, a drug metabolized by the CYP2D6 enzyme, because use of the two drugs together may increase the amount of thioridazine in the blood and cause an abnormal heart rhythm that can be serious.

The most common side effects in patients treated with Varubi include a low white blood cell count (neutropenia), hiccups, decreased appetite and dizziness.

For more information, please visit: Varubi
.

Medical Device Safety and Recalls: Dräger Medical, Evita V500 and Babylog VN500 Ventilators – Faulty Batteries

Medical Device Safety and Recalls: Dräger Medical, Evita V500 and Babylog VN500 Ventilators – Faulty Batteries

A recall has been issued for the Dräger Medical, Evita V500 and Babylog VN500 Ventilators – Faulty Batteries
. The battery (part of the PS500 Power Supply Unit) that powers the Evita V500 and Babylog VN500 Ventilators does not last as long as expected. The battery indicator light shows a sufficiently charged battery even when the battery is depleted.

When the “battery low” and “battery depleted” alarms sound, the devices do not indicate how much time is left before the ventilator will shut down due to lack of power. Analysis by Dräger indicates that the battery should last approximately 30 minutes. If the power is lost, the 30-minute battery back-up should last until the ventilator is connected to a main power supply.

If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.

FDA.gov

Medical Device Safety and Recalls: Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed

Medical Device Safety and Recalls: Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed

A recall has been issued for Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed
. When the ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician.

If a patient does not receive the amount of air set on the machine, they may need to be removed from the ventilator and placed on a different system. A patient not receiving enough oxygen, can result in possible injury or death.

FDA.gov

Drug Information Update – FDA approves new orphan drug to treat rare autosomal recessive disorder

Drug Information Update - FDA approves new orphan drug to treat rare
autosomal recessive disorder
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public
inquiries. We serve the public by providing information on human drug
products and drug product regulation by FDA.

------------------------------------------------------------------------

On Friday September 4, 2015, the U.S. Food and Drug Administration
approved Xuriden (uridine triacetate), the first FDA-approved treatment
for patients with hereditary orotic aciduria. Hereditary orotic aciduria
is a rare metabolic disorder, which has been reported in approximately
20 patients worldwide.

Hereditary orotic aciduria is inherited from a recessive gene. The
disease is due to a defective or deficient enzyme, which results in the
body being unable to normally synthesize uridine, a necessary component
of ribonucleic acid (RNA). Signs and symptoms of the disease include
blood abnormalities (anemia, decreased white blood cell count, decreased
neutrophil count), urinary tract obstruction due to the formation of
orotic acid crystals in the urinary tract, failure to thrive, and
developmental delays.

No side effects were observed in patients treated with Xuriden for up to
nine months.

For more information, please visit: Xuriden
<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwOTA4LjQ4ODQwMTAxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDkwOC40ODg0MDEwMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTg0MzQ2JmVtYWlsaWQ9bWVtYmVyc2hpcEByYWVjbGluaWNhLmV1JnVzZXJpZD1tZW1iZXJzaGlwQHJhZWNsaW5pY2EuZXUmZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm457867.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery>

Drug Information Update- Updated Warnings for Safe Preparation and Handling of Treanda (bendamustine HCl) Injection for Intravenous Administration

Drug Information Update- Updated Warnings for Safe Preparation and
Handling of Treanda (bendamustine HCl) Injection for Intravenous
Administration
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public
inquiries. We serve the public by providing information on human drug
products and drug product regulation by FDA.

------------------------------------------------------------------------

On March 10, 2015, the FDA issued a statement warning health care
professionals not to use chemotherapy drug Treanda Injection (45 mg/0.5
mL or 180 mg/2 mL solution) with closed system transfer devices (CSTDs),
adapters, and syringes containing polycarbonate or
acrylonitrile-butadiene-styrene (ABS).

As an update, FDA is providing information on specific devices tested by
Treanda manufacturer Teva Pharmaceuticals and found compatible with
Treanda injection (See Tables 1 and 2).  Treanda (bendamustine
hydrochloride) is used to treat patients with chronic lymphocytic
leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has
progressed during or within six months of treatment with rituximab or a
rituximab-containing regimen.

For more information, please visit: Treanda
<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwOTA0LjQ4NzcwNDMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDkwNC40ODc3MDQzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTgzNzEyJmVtYWlsaWQ9bWVtYmVyc2hpcEByYWVjbGluaWNhLmV1JnVzZXJpZD1tZW1iZXJzaGlwQHJhZWNsaW5pY2EuZXUmZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&http://www.fda.gov/Drugs/DrugSafety/ucm437469.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery>.

Drug Information Update- Updated Warnings for Safe Preparation and Handling of Treanda (bendamustine HCl) Injection for Intravenous Administration

Drug Information Update- Updated Warnings for Safe Preparation and
Handling of Treanda (bendamustine HCl) Injection for Intravenous
Administration
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public
inquiries. We serve the public by providing information on human drug
products and drug product regulation by FDA.

------------------------------------------------------------------------

On March 10, 2015, the FDA issued a statement warning health care
professionals not to use chemotherapy drug Treanda Injection (45 mg/0.5
mL or 180 mg/2 mL solution) with closed system transfer devices (CSTDs),
adapters, and syringes containing polycarbonate or
acrylonitrile-butadiene-styrene (ABS).

As an update, FDA is providing information on specific devices tested by
Treanda manufacturer Teva Pharmaceuticals and found compatible with
Treanda injection (See Tables 1 and 2).  Treanda (bendamustine
hydrochloride) is used to treat patients with chronic lymphocytic
leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has
progressed during or within six months of treatment with rituximab or a
rituximab-containing regimen.

For more information, please visit: Treanda
<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwOTA0LjQ4NzcwNDMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDkwNC40ODc3MDQzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTgzNzEyJmVtYWlsaWQ9bWVtYmVyc2hpcEByYWVjbGluaWNhLmV1JnVzZXJpZD1tZW1iZXJzaGlwQHJhZWNsaW5pY2EuZXUmZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&http://www.fda.gov/Drugs/DrugSafety/ucm437469.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery>.