» Pharmaceutical
» Health Care IT
» Drug Manufacturing QA/QC
» Disease Discovery
» Hospitals
» Clinics
» Genomics
» Drug Discovery
» Drug Testing

HCM TEK provides a variety of application development, application and infrastructure support services to various pharmaceutical and life science companies. The process of generating new chemical entities demands the management of vast amounts of data in order to generate more qualified leads. The study of the structure and functions of genes, their resulting proteins, and the roles they play in the body's biochemical processes. Understanding genomics will bring about a revolution in our understanding of disease mechanisms and prevention. To achieve this goal, HCM TEK has desinged the way researchers collect & purify, and quantify & characterize DNA and RNA.


Offerings

Health Care Content Management
» HCM products help organizations capture information, streamline business processes, share knowledge and access relevant information while becoming more efficient and complying to corporate regulations
» Web-based electronic data management that collects, organizes, indexes, stores, archives and shares electronic records - from raw analytical instrument data and reports to compliance records, MS-Office documents, PDF documents, molecular drawings, pictures and video. HCM automatically extracts searchable metadata from each of the files, and provides powerful search capabilities and embedded viewers for many file types. As a result, knowledge workers find information faster and make more informed decisions.

Clinical and Lab Data Management
» HCM TEK has expanded our portfolio of laboratory informatics software for the clinics and laboratories The integration of the two department' software solutions addresses the complete life cycle of analytical information-from data acquisition to knowledge management and retention. HCM TEK's combined software products gives you access to an open system architecture that can integrate applications, instruments, and data into a rich source of information and control of your lab regardless of vendor.
» Development of screens for data entry using HL7,  EHR Solutions, HIS and RIS
» Data entry from Case Report Forms (CRF)
» Data validation (writing consistency checks and producing clarification requests)
» Data cleaning/correcting
» Quality check of the data
» Documenting safety data
  * Note: All processes adhere to Good Clinical Practices (GCP)

Statistical Analysis and Modeling
» Clinical trials data arriving on case report forms is fairly standard, for example demography, adverse event, medications, laboratory etc hence can be stored in fairly standard data structures. Designing clinical data structures for data entry is important, but it should be done with some understanding of the analysis that will be performed. Once an appropriate clinical data structure is arrived at for data entry, it is important to then determine how to best use the data in the SAS analysis environment.
» Statistical input for protocol development, sample size estimation, randomization code generation
» A primary goal of the research is to provide theoretical justifications and software for a very broad range of robust modeling and analysis methods which provide a good fit to the bulk of the data in the presence of outliers, enable rapid identification of outliers, and provide good statistical inference results.
» Development of analysis plans for phase I-IV (parallel to high order cross-over studies)
» Statistical analyses and exploratory analyses for phase I-IV trials
» Independent statistical work for IDMC (Independent Data Monitoring Committee for Safety Monitoring)
» Un-blinding randomization
» Interim monitoring analysis
» Generation of clinical study reports for submission

Data Warehousing and Mining

A company's collected raw data is an important asset where one can find solutions to many of an organisation's critical questions like 'what was the net profit for a particular product last year and what will be sales this year and what are the key factors to be focussed this year in order to increase the sales. So there arises a necessity of a well planned BI system which can lead to a greater profitability by reducing the operating costs, increasing the sales and thereby improving the customer satisfaction for an enterprise.
» Data extraction from databases
» Data normalization/standardization
» Data aggregation
» Recursive & sequential partitioning

Data Mining
» Find out the Business Problem: Consider a company's current year sales dropped by a percentage when compared to the previous year. By using OLAP Tools, the exact sales fact can be determined across several dimensions like region, time etc.
» Knowledge Discovery: Given this business problem, various reasons for the decrease in sales have to be analyzed utilizing one or more of the Data Mining Techniques. Causes may include poor quality or service of the product or flaws in marketing schemes or less demand for the product or seasonal changes or regulations enforced by the Government or competitors pressure, and so on. The exact solutions have to be found out in order to resolve this sales drop, which we call it as the Knowledge Discovery here.

Statistical Analysis and SAS Programming for Phase I-IV Clinical Trials
» We offer clients a comprehensive set of clinical research and informatics services including project management, clinical monitoring, medical monitoring, data acquisition and management, statistics, medical writing, investigative site auditing, and electronic clinical trials
» Pre-Clinical and Clinical Program Consultation
» Protocol Design & Development
» Survey Design & Implementation
» Statistical Analysis Plan Development
» Randomizations
» Statistical Programming Using SAS
» Epidemiological Analyses (including study design)
» Phase I-IV Statistical Analyses
» Creation of summary tables, listings and graphs for efficacy and safety analysis per ICH guidelines
» Data normalization and standardization

Application Development
» Creation of user-friendly displays using VB or SAS/AF
» Integration of GUI front end with SAS macros
» electronic clinical trials in order to bring their drug or device to market quicker, with a better ROI on their people and technology. However, the cost of licensing multiple, enterprise-wide technology systems is often prohibitive for small- to mid-sized companies. To help these and other organizations achieve a competitive edge, HCMTrail Clinical Informatics has partnered with SAS to combine the critical operational and data aspects of an electronic clinical trial in one secure, Web-based collaborative workspace
» SAS-programming is very important from preclinical testing to approval stages. Here, when you see the sequence of drug development and approval process you can yourself realize how important clinical trials and SAS-programming areas are and there is an urgent need of starting training programs in these areas.
 
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