Solutions consulting


Our services address critical needs in the areas of enterprise management, clinical data management, safety reporting, electronic data capture, electronic content and data management, dictionary management, clinical trial management, biostatistics, and bioinformatics. We specialize in assisting our clients to select off-the-shelf vendor-supplied systems, and configure and implement the same to their unique business requirements, given their time and budget constraints. Our expertise lies with implementing some of the market leading clinical systems. We have expertise in the following subservice areas:

 

 

 

Strategy Development
 

To develop the drug safety, biostatistics, or clinical systems implementation strategy, we partner with clients to:

  • Analyze existing IT infrastructure and systems architecture

  • Assess the IT support required to efficiently enable systems implementation strategy

  • Perform cost-benefit analysis for maintaining the systems in-house vs. outsourcing

  • Define user requirements for your systems

  • Develop recommendations for hardware and systems architecture

  • Generate RFPs to select vendor systems that best fit the needs

Develop a system integration and validation strategy for the selected applications.

 
Clinical Safety Systems

 

Clinical safety systems are used by companies to manage and report their products' Adverse Events. The medical device companies also use it for storing their product and service complaint data.

 

These systems are used during the clinical trials phase and for post-market trials. We have expertise in AERS™ from Oracle Corporation.

Our service offerings include, but not limited to:

  • Define functional requirements

  • Evaluate available off-the-shelf systems based on the defined requirements

  • Install and configure the software

  • Define business processes

  • Develop required SOPs and guidelines

  • Develop and/or execute Operational Qualification Protocol (OQP)

  • Develop and/or execute Performance Qualification Protocol (PQP), based on the defined business processes

  • Conduct training on the use of the system and also carry out system pilot

  • Integrate the clinical safety system with standard dictionary and/or dictionary maintenance system such as TMS

  • Migrate data from legacy systems, along with customization and upgrades

Develop SAE reconciliation reports with Oracle Clinical.

 

 

 

Clinical Data Management Systems

 

We can help companies analyze their needs and assist with selecting the right solution to efficiently manage their clinical trials data.

Our expertise lies with implementing the market leading Clinical Data Management system – Oracle Clinical™ from Oracle Corporation.

Oracle Clinical is a powerful, comprehensive clinical data management solution. Oracle Clinical allows companies to standardize and control data definitions and data usage across a global operation, ensuring that data is defined, managed, and interpreted consistently worldwide. This expedites the multinational regulatory approval process and reduces cycle times in critical clinical trial processes, thereby accelerating time to market for new products.

Oracle Clinical is the heart of an integrated suite of applications supporting the clinical research process. The suite also includes Remote Data Capture for entering and managing data from the investigative site, Thesaurus Management System for classifying investigator terms against medical dictionaries, and the Adverse Event Reporting System for managing product safety.

 

Remote Data Capture

 

Remote Data Capture (RDC) systems have existed for over a decade; however, their acceptance has been hampered by poor communication infrastructure and sites inexperienced with the use of computer systems. With the recent widespread availability of Internet connections and improved usability and performance of RDC applications, many companies are beginning to replace paper-based case report forms (CRF) data collection with remote data entry.

We have expertise in the Oracle RDC™ systems. We can help you re-engineer your business processes to accommodate remote data capture needs, assist you with restructuring your IT infrastructure to support higher-level requirements around security implementation and authentication of remote site connections, and conduct training for in-house staff and site personnel on the use of these systems.

 

Data Management

 

We have data management experts with Oracle Clinical and TMS experience who can assist companies with the following services:

  • Setup of data management policies and procedures

  • Development of Global Library objects

  • Setup of studies in Oracle Clinical

  • Development of validation and derivation procedures

  • Resolution of discrepancies

  • Maintenance of dictionaries

  • Coding of adverse events and medications

Migration of clinical data from legacy systems to Oracle Clinical, TMS, and AERS.

 
SAS Implementation and Programming

 

Our top minds and top technology are dedicated to serve the ever-growing business intelligence world and to meet our customers' growing needs.

Our focus is to ensure the integrity of your data and organize your results into a clear and result-oriented presentation.

Our SAS Services include:

  • Implementation and validation of SAS on Windows and UNIX operation systems

  • Protocol development/Sample Size planning

  • Analysis plan development

  • Randomization planning and implementation

  • Strategic development consulting

  • ISS/ISE database preparation and analysis

  • Data mining/exploratory analysis

  • SAS programming for interim and final analysis

  • Regulatory and advisory meeting support

Our statisticians, all having a PhD or an MS degree, are familiar with regulatory requirements and skilled in robust statistical methodologies. Our statistical programmers are highly flexible and experienced in using SAS, thus enabling us to generate and QA report summaries and listings as per your specifications.

 

 

 

Electronic Document and Content Management

 

Our Knowledge Management experts combine industry leading tools, best practices, business and technical services, and our comprehensive methodology to ensure successful adoption of a document and content management solution. Our experts provide assistance with the implementation of business processes underlying new technologies as well as the technical aspects of deployment. To ensure that our solutions provide lasting value and sustainable competitive advantage to our clients, we view document and content management solutions from multiple perspectives – addressing the people, communication, process, marketing, and technology factors. Our expertise lies with implementing the market leading off-the-self 21CFRPart11-compliant Knowledge Management system – Livelink, QMAS, MasterControl, Documentum, etc.

 

Dictionary Management

 

Dictionary management systems are used by companies to maintain and customize medical dictionaries necessary to code their clinical trial Adverse Events (AEs) and medications.

We have expertise with setting up systems such as TMS™ (Thesaurus Management System). We can help you use these systems in conjunction with Oracle Clinical™ and AERS™ applications to facilitate the coding efforts, using standard Drug Dictionaries – MedDRA, COSTART, WHO-DRUG, and WHO-ART.

 

 

 

Installations and DBA support

 

We can assist you with the following:

  • Plan, select, install, and configure hardware

  • Install/upgrade Unix, Windows operating systems, and Oracle RDBMS

  • Install/upgrade Oracle Clinical, TMS, AERS, and other clinical applications

  • Load/upgrade your preferred dictionaries into TMS

  • Install failover servers to ensure uninterrupted operations in case of hardware or system failures

  • Upgrade existing systems to new versions, and install patches as necessary

All installation and configuration effort is accompanied by complete documentation following regulatory requirements and industry standards.

Systems Development and Integration

 

We can develop a custom solution or carry out enhancement to a vendor system based on our clients' needs. We can also help seamlessly integrate drug safety and clinical applications from both process and systems viewpoints. We have assisted our clients with development of the following system solutions:

  • Integration of Interactive Voice Response System (IVRS) with Oracle Clinical

  • Reconciliation reports between Oracle Clinical and other Adverse Events Systems

  • Encoding solutions for dictionary management systems

  • Developing custom forms and reports

All development projects are delivered with complete source, validation, and user documentation.