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Clinevo Technologies

We provide IT consulting services to assist our clients with their ever–changing needs in the dynamic IT environment. Our goal is to help them to continuously improve the effectiveness & efficiency of their IT application environment by adopting and evolving towards re-usable software platforms. We help clients analyze business and/or technology problems in order to identify and design platform based solutions. We also assist our clients in planning their IT initiatives and transition plans.

The biggest difference with us is that we always strive for best results through close collaboration with our clients to understand their problems. Our consulting team would become the extended IT team of the client and completely take over the ownership & responsibility of the end to end IT services.

We offer the following consulting services:

  • Assessment of current IT environment
  • Application performance analysis and recommendations
  • Vendor and application selection
  • Vendor audit
  • Business case development and cost analysis
  • Requirements and design management
  • Pilots and proof of concepts
  • 21 CFR Part 11 guidance
  • Business process management
  • Business process reengineering
  • Best practice analysis and recommendations
Clinevo Technologies

With a combined experience of more than 15 years in the life sciences IT industry, we will be able to suggest the software that is best suited for your needs. We have extensive experience in evaluating, implementing and maintaining the best among the latest options available for your business. We help you determine the exact requirements of your business. We further assist you in choosing the product and vendor that shall meet your needs well within the framework of your budget. The right software creates a productive and cost-effective business environment so that all your focus can be on science.

We assist you with the planning, analysis, configuration and validation of the solutions you purchase. By optimizing your implementation and validation process, we ensure that you quickly begin your business with new software that meets your company standards and regulatory guidelines.

Our end-to-end implementation services include:

  • Implementation strategy and roadmap
  • Implementation and customize to business requirements
  • Validation, Maintenance and Support

Life Sciences Applications we expertise include:

Pharmacovigilance (PV) / Post marketing / Safety:

  • Oracle Argus Safety
  • ARISg

Clinical Data Management (CDM):

  • Oracle Clinical (OC) / Remote Data Capture (RDC) / Thesaurus Management System (TMS)
  • Medidata RAVE

Data warehousing and Analytics:

  • Oracle Life Sciences Data Hub (LSH)
  • Oracle Data Management Workbench (DMW)
  • Oracle Clinical Development Analytics (CDA)
Clinevo Technologies

Effective IT management in an extremely methodical life sciences industry requires a dedicated and highly qualified team to ensure that the system is available 24/7/365 for business.

You may not have the staffing capability to build your own IT team. Especially, the one with varied experience. That is where we will help you by being your extended IT team.

We have a well-qualified team to maintain, support and ensure that the system is available 24/7, while being compliant with all the regulatory standards.

Support services we provide for Life-sciences applications include:

  • Help business in Troubleshooting functional issues
  • Application maintenance
  • Administration
  • Regular health checkups
  • Applying bug and security patches
  • Troubleshooting and fixing technical issues

Our support channel includes:

  • Live chat
  • Phone calls
  • E-mail
  • Remote Access
  • Knowledge base

We’re here to Support You

You can request support at any time, any day and we are available 24/7/365.

Clinevo Technologies

System Integration is not only a new trend, but an effective solution which can bring in a lot of value to the business. Any business application is incomplete if it does not include an all-inclusive tool to increase productivity.

Our team has extensive experience in integrating businesses and applications for Life Sciences customers.

Some of the key integrations we expertise in includes:

  • Oracle Argus with any other source / target / reporting systems
  • Custom / homegrown clinical and Safety applications with any other applications
  • Oracle LSH with third-party tools
  • Oracle Clinical / Medidata RAVE / any clinical application with Interactive Voice Response Systems (IVRS)
  • Oracle Clinical with any Imaging Systems

Benefits of Utilizing Integration services includes:

  • Improved and streamlined business processes by Integrating the transaction systems with source systems
  • Reduction in maintenance and technological costs by Automated data flow between systems
  • Elimination of redundant tasks by tight Integration between systems
  • A highly skilled and experienced workforce
  • Customized business improvements
  • Fully supported, intelligent systems
Clinevo Technologies

Organizations need to upgrade their IT systems and applications to stay in sync with the cutting-edge technology. Organizations must constantly upgrade IT Life Sciences systems and applications to support business growth objectives. Upgrades should be planned and managed effectively, so as to avoid business disruptions.

With a great level of expertise, we provide comprehensive support for upgrading your systems to meet your business goals and to comply with worldwide regulatory guidelines.

Recent versions of several system upgrades we specialize in include,

  • Argus Safety Suite to 8.X
  • Oracle Clinical / Remote Data Capture (RDC) to 5.X
  • Thesaurus Management System (TMS) to 5.X
  • Oracle LSH version installation and upgrades
  • OCDA upgrades

Our upgrade assessment and upgrade services will address the following:

  • Perform impact analysis on business processes and facilitate customizations
  • What necessitates an upgrade? Should the system be upgraded or re-implemented?
  • How many of the existing extension, interfaces and reports will need to be reworked for it to be able to work with the upgraded application
  • Upgrade complexity assessment
  • Identify pre upgrade and post upgrade tasks
  • Validations required for the upgrade
Clinevo Technologies

Our application developers plan and create customized, mission-critical applications that are unique to your business. Our team invests quality time & efforts to assess your current business needs, in order to create an application that can be seamlessly integrated into your current workflow, greatly reducing the downtime associated with training.

Much of the off-the-shelf software are built for the masses and sometimes it just isn’t sufficient. You need your custom, special application, because you have unique requirements and goals.

Let our application developers use their industry knowledge to deliver to you, the applications that match your requirements and specific business goals. Your business deserves an application that not only integrates itself seamlessly, but also makes your business operations more efficient.

Our innovative application development process and in-depth knowledge of the life sciences industry allows you to

  • Meet your business objectives and requirements
  • Reduce the total cost of ownership
  • Be in compliance with 21 CFR Part 11
  • Achieve flexibility and scalability
  • Increase productivity

Our application development advantage:

  • The combination of domain and technology expertise results in reduced time-to-market for new products
  • An optimal onshore/offshore balance helps in reducing IT labor costs for new deployments and maintaining existing functionality
  • Our proven processes, tools and methodologies help reduce backlogs in business demands and improve responsiveness to changing business needs and technologies
  • Our innovative methods help in improving the efficiency of application performance and result in enhanced customer experience
Clinevo Technologies

Companies conduct data migration projects for many reasons: corporate events like mergers & acquisitions (many sources to many targets), new business models or processes (one-to-one), or to keep pace with technical progress or consolidating applications (many-to-one). Almost all migrations involve data transformations to get the data from one model to another. Transformation addresses data quality issues such as name-and-address cleansing, deduplication and standardization.

Data is one of the most important assets that a company owns. Data is collected and analyzed to create information for decision making. Data influences patient safety or product quality in Life Sciences. We understand that if data is transferred to another data format or system, validation should include checks that ensure that the data is not altered in value and/or meaning during this migration process.

Data migration projects are often underestimated. Migrations are complex, as multiple data sources have to be harmonized and data quality is essential for Life Sciences compliant systems.

To prevent costly future business process interruptions and to achieve compliance, it is recommended that all iterations should follow a clearly defined model.

Our data migration experts deploy a number of approaches, products, as well as third party solutions to analyze the existing processes, plan the transition, obtain buy-in and migrate data, content & metadata to perform in-depth validations in order to ensure migration quality & regulatory compliance are intact.

With our data migration expertise, we know how to

  • Manage end to end data migration activities with in-depth understanding of business processes and key data used in each of the processes
  • Extract, transform and transfer the data
  • Handle legacy audit trial information and the data verification approach
  • Select appropriate ETL tools & techniques and determine whether these need to be validated

The key benefits of the above structured approach are:

  • Reduced risk – establishing a repeatable and scalable process minimizes errors
  • Budget control – avoid costly overruns by finishing the tasks in time
  • Increased governance – establish an effective and efficient information governance process that meets GxP regulations through up-to-date documentation (rules and decisions)

Some of the Data migration with which we can help your organization, include

  • Adverse Event Reporting System (AERS) to Argus Safety
  • ARISg to Argus Safety
  • Excel to Argus Safety
  • Clinical data to Oracle Clinical, Medidata RAVE instances
  • Any homegrown/legacy system to any Oracle application
Clinevo Technologies

Our innovative teams have expertise to help clients in hosting their clinical and safety applications in a state-of-the-art data center and provide a comprehensive set of services to manage them.

Server and Application Management:

  • We proactively update, back up, monitor and manage all your servers & applications remotely. Every aspect is closely monitored so that the issues can be identified and fixed before they can cause a problem. You shall be best assured that your data and systems are being monitored and protected by our dedicated support team 24/7

Application Support / Help Desk:

  • Get quick support over telephone or by submitting & tracking a help ticket online, 24 hours a day and 7 days a week via our unique application support system. We can fix most of the problems remotely, so that you can be back, up and running without having to wait for a technician to come to your office for help. We can help you with both application and server issues
Clinevo Technologies

The practice of software validation is a distinguishing characteristic of the life sciences industry. The FDA requires any software that touches the regulated process to be validated. This software must be tested and managed in a way that demonstrates its performance as intended by the end user.

Software validations serve an important purpose in Life Sciences Industry - ensuring that the software being used to maintain Part 11 records do so, with accuracy, reliability, integrity, availability and authenticity. However, life science companies validating software against 21-CFR-Part 11 are aware about how resource intensive validation can be.

  • We have a dedicated team of validation & compliance experts with a proven and methodical approach to systems validation that saves your time and resources, thereby reducing the high costs associated with validation
  • Our validation products and services specific to the Oracle Health Sciences application suite can offer custom validation services that are tailored to fit your organization's needs, including quality systems gap analysis and third party user acceptance testing
  • Our validation experts can prepare a range of requirements for validation process, from Validation plan to Validation summary and help in IQ/OQ and PQ process and documentation. We also have validation accelerators through which the documentation process can be speeded up and compliance with Computer system validation guidelines and 21 CFR Part 11 guidelines can be achieved
Clinevo Technologies

We can help you with paper or electronic study setup activities with the initial setup of studies and ongoing support including

  • Annotated CRF/e-CRFs
  • Data management plans and CRF/eCRF completion guidelines
  • Data specifications documents
  • Procedure specifications (e.g., edit checks)
  • Validation and derivation procedures
  • Data extract views
  • Test data preparation and testing

Our Data management experts have extensive study build experience using Oracle clinical / RDC / TMS and Medidata RAVE.

Call us now:
080 – 481 481 38

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