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Services

 

 

Our Services include a wide spectrum of solutions to successfully manage clinical trials.

With over 20 years of experience in the Life Science industry, we can ensure that we will not create work-arounds. We will only create real solutions.

 

Customized Solutions

* We understand that every company is different and that no one system can offer a solution to fit everyone's needs.

* Our customized solutions are geared towards the client requirements and expectations.

Customized add-on tools (payments, adverse event classification, lab-loader, query resolution, drugs, etc...)

Our customized tools are meant to automate processes and provide the client with utilities to help with the day to day process.

 

 

Strategy Development

  * Our team can analyze current infrastructure and architecture.

  * We can define current requirements, develop cost-benefit analysis and help generate RFPs to select vendors that best fit your needs.

 

Validation and QA

  * Our validation experts have broad knowledge in validating current systems and tools.

  * We can help in validating vendor systems.

 

Compliance Services

  * With many years of experience in regulatory enviornments, our consultants can perform complete 21 CFR Part 11 assessment of your current systems.

  * Vendor audits can be performed by our staff to maintain FDA's requirements.

 

Standardization

  * Let us help you standardize current SOPs, Procedures and CRFs.

  * We can apply CDISC and SDTM standards to make sure you comply with industry standards.

 

Data Analysis / Biostatistics

Our consultants have worked on many projects providing analysis and statistics through various streams and different tools. Let us assist you in providing the data needed and help in the data decision making.

 

Data Management Consulting

Our data management consulting group has over 10 years in experience with different Data Management tools. We can help design studies, design Case Report Forms, develop reports and provide data cleaning. Our consulting team has experience using the CDMS tools listed below.

 

Clinical Data Management Systems

  Oracle Clinical

  Clindex

  eRT

  Access

 

Recruiting

  * With our broad knowledge with Pharma and Device companies, we can help you find the best of breed for your needs.

 

Today's Concerns for Healthcare Providers

We work with organizations to eliminate concerns such as;

Data Availability
Requiring data to be available with an adequate level of performance is un-negotiable for a Heathcare provider.

Scalability
Seemingly scalable infrastructure should always be able to meet the needs of medical practitioners. They require the ability to access complex and large data objects like MRI scans and other patient records over a distributed network.

Disaster Recovery
In today's healthcare industry, reliability of systems and continuous access to data at all times is not merely a business concern but a safety concern as well.

Solutions Integration
The Patient always comes first. Therefore, easily accessible information like Lab results, patient history, and drug interaction will better guide a practitioners decision-making.

Data Management
Archiving and Information Life Cycle Management will become critical issues as an infrastructure grows.

Security
A Secure Infrastructure is vital to the protection of a Patient's confidentiality .

 

 

Hospital and Clinic IT Solution

Patient EMR (Electronic Medical Record)

Medical Image Archiving

Online Patient Questionnaire.

Lab Data