HepTronik’s unique expertise provides customers with the most robust solutions in the industry.
Solutions
Whether your business sells products or provides services, you can no doubt benefit from knowing more about your customers and their opinion about your new or existing offerings. Heptronik in the market research and clinical trial industry have developed a wide variety of processes to collect and analyze any data that may be relevant to your business. While gaining a better understanding of your customers is a constant challenge, finding the right the market research firm to assist you can be an equally daunting task. This is where Heptronik can help.
Heptronik is the leading provider of market research and Clinical trial services. We specialize in connecting pharmaceutical business to target market research by utilizing our extensive expertise. Regardless of the size of your company, Heptronik can assist you in combining in-depth domain expertise, sophisticated analytics and world-class technology to deliver measurable and actionable results that significantly improve the performance of brand portfolios and pharmaceutical sales forces.
We offer best in class practices in:
- Clinical trial design, implementation, analysis and reporting
- Clinical data management and statistical analysis
We welcome your suggestions and encourage you to pursue our entire line of market/clinical research capabilities.
Specialty Market Research
We provide global solutions in sales and marketing tracking, analysis and planning as well as fast-turnaround market research services. Our web-based solutions provide a collaborative environment, enabling our global customers to execute efficient and focused sales and marketing programs. Our unique tools and methodologies align tactics with strategy; facilitating faster and more transparent implementation of optimal strategies.
Customers leverage our solutions and services to:
- Characterize and enhance their sales and marketing development processes
- Install common Key Performance Indicators and metrics to enable tracking and planning across brands and geographies
- Perform strategic and tactical planning, resource optimization and market driven forecasting
- Perform analysis on a wide variety of data to determine the effectiveness of sales and marketing
- Restore visibility for sales and marketing executives, facilitating rapid action and strategy deployment
- Enable ROI driven multi-channel planning of promotional activities
- Characterize and improve physician access and relationships
- Perform high quality, rapid-turnaround market research across the drug lifecycle to answer critical sales and marketing questions
- Perform end-to-end commercialization of brands in specialty pharmaceutical
Advanced Clinical Research
More than 80,000 clinical trials alone are conducted in the United States per year and about 95% of them are still paper-based. So it is not surprising that as life sciences organizations seek ways to drive efficiency and improve performance, one of the areas most closely scrutinized is the clinical development process. Although technological developments have enabled life sciences organizations to gather, process, and communicate clinical trial information more quickly, most of the information technology investments have been in point solutions, applications that address requirements to a particular point in the process. In other words, companies have simply adapted their existing systems to meet the new challenges rather than revising the clinical process as a whole. As a result, some organizations may have between 25 and 30 software applications requiring integration, support, and maintenance.
Data collection and management currently account for up to 60% of the overall clinical trial process, a timeline that drug companies increasingly find unacceptable as they face increasing pressures to test, approve, and market new drugs faster than ever before. Introducing an integrated content management solution to automate the documentation process relevant to clinical trials and related activities can help cut the time for these trials by two-thirds.
HepTronik Clinical Trials streamlines the clinical trial process by capturing, authoring, processing, and managing clinical documentation. By standardizing, controlling, and securing clinical trials-related content, HepTronik Clinical Trials reduces the costs of data acquisition and clean up during trials, enables real-time decision-making based on immediately accessible data, and ensures regulatory compliance and faster submission preparation.
Clinical trial operations management has relied on an inefficient combination of manual paper-based procedures and a variety of non-descriptive and in-housed developed software applications. Typically, software applications were implemented as self-contained, point solutions with little in the way of design considerations for integration with other applications or business processes that are traversed functional areas. More generic product means more competition in off patent market. More competition in off-patent market means more low-price products. More low-price products in off-patent market mean more resources for innovative products.
More innovative products to be generated mean early identification for candidate for drug research.
Therefore the issues mentioned above puts a great importance for quick turnaround of the studies, to prudently use the financial and human resources without repeating to do the same things again and again.
The use of electronic data interchange and the internet as an effective and secure mechanism for data transportation, information sharing, and collaboration have been achieved across number of critical financial and manufacturing sectors with a velocity that suggests it safe for the clinical trial entities to move aggressively, effectively and more forcefully.
Customers leverage our solutions and services to:
- The concept is to synchronize process and increase automation across islands of information, providing systemic improvements to R & D process
- Cross – functional, a holistic process approach, in-depth domain approach, knowledge leverage the use of technology
- Accelerated clinical trials, anyone can create a great looking web-enabled CRF quickly and easily with one-button click to deploy. The back-end engine of business intelligence takes care of the rest. No coding, no waiting, just action results
- It is easy, fast and real-time. eXcileCR streamlines the clinical trial process by capturing, authoring, processing, and managing Trial Master File and high-volume Case Report Form documentation. Rapid implementation gets you started immediately to reap the benefits sooner
- Harvest clinical data to improve early decision-making, early access to the information
- Monitor trends in promotional impact market research and safety, efficacy of new compounds in clinical trials
- Distribution real-time information and educate all concerned stakeholders, participants utilizing a customized web-portal
- Establish global standards for conducting research and exchanging information
Faster approval times, more drugs in the pipeline and drug development costs managed more effectively - Minimized noncompliance risks
Thought Leader Evaluation
Heptronik can help you maximize the brand awareness benefit you derive from your “Thought Leaders”. While these individuals are well respected and knowledgeable, you are making a significant investment in identifying, training and promoting them. You want to make sure the thought leaders satisfactorily deliver to your audience an increased awareness of your brand and its proper use. Heptronik can help you evaluate the effectiveness of speakers in terms of their peer audience and their own prescribing habits. We can help assess whether or not peer to peer programs are increasing appropriate drug utilization and sales. The analyses we provide are easy to understand and presented in an actionable format.
As the head of the marketing and sales in a Pharmaceutical organization, one of the tasks is to have a system in place, which will help to track and perform Return on Investment Analysis (ROI) for multi-channel promotion. This system will allow the Medical Science Associate (MSA) and Territory Reps. to record all promotional, contact, rating, tier and ranking information electronically and automatically generate reports/charts based on different search criteria.
The system is a web-based application, which will allow the Territory Reps. and the Medical Science Associate to enter attendee information, ASO/CSO, Program evaluation and create various reports and charts. For the reasons of security and auditing, MSA and Territory Reps .can only access and edit their own Territory and Program Evaluations.
The system will retain information of all the Key thought leaders identified by your Company. The system will also retain information on all the MSA and Territory Reps. in the company who need access to the system.
The MSA and Territory Reps. will update the physician contacts and the details on a weekly/fortnightly basis. The data Rx for the Key thought leaders has been made available for the MSA and Territory Reps. to see the percentage increase or decrease after any promotional event. This system can keep track of the events, associated cost and the changes in the Rx information. (6-12 months of Rx data to be made available through any data-mart).
The most requested feature of the system is the physician and product wise promotion and cost reporting. Also based on the levels in the company the mangers will be able query the system for different kinds of reports.
There are few standard reports, which have to be calculated offline and integrated into system every month. To calculate these reports fresh data feeds have to be loaded. The system is being designed so that the reports, data load will always be generated automatically and there will be no need for any manual intervention.
The Promotional Analysis reports needs offline analysis and it will be made available as non-editable PDF files. Any search results can be downloaded in to the following formats (PDF, CSV, excel) for further analysis.
Customers leverage our solutions and services to:
- Characterize and enhance their sales and marketing development processes
- Perform strategic and tactical planning, resource optimization and market driven forecasting
- Perform analysis on a wide variety of data to determine the effectiveness of promotional activities
- Enable ROI driven multi-channel planning of promotional activities
- Characterize and improve physician access and relationships
- Ability to take informed decisions for developing marketing strategy
- Better use of NRx and TRx data for effective communication
- Focus on important issues in a timely and organized fashion
- DM and RM can do an audit and generate reports of reps. giving more transparency and accountability in the process flow
- Access to the application from virtually any desktop
Statistical Programming Services
Heptronik’s programmers have a wide array of experience including SAS®, ASP.NET, VB.NET, Java, HTML, ASP, Active-X, XML, SQL, and other integrated languages. Heptronik’s programming staff works closely with the Sponsor, Biostatistics, Clinical Data Operations, Clinical Program Management, and Customer Support Services personnel to produce consistent, high-quality results. Our programmers generate and maintain all code for statistical analyses of clinical data, safety summaries, and health economic projects.
Heptronik’s programmers perform blinded dual analysis to ensure maximum accuracy. Heptronik’s statistical programmers/Data Management team also provide input into CRF design, annotation of CRFs, Clinical Data Operations Guidelines, data analysis plans, narratives, and clinical study reports
Programming Services
- Design of presentation-ready reports with graphics
- Generation of automated data reports
- Programming of special requests and analyses
- Data transfers
- Generation of site payments
Requests for Custom Programming
If you would like to submit a request to receive a cost estimate and timeline for Heptronik’s to perform custom programming, or to be contacted please click here should take to
Biostatistics
Heptronik’s biostatisticians provide their clients statistical computing support, with expertise in areas of statistical inference, regression analysis, multivariate methods, applied probability models, sampling techniques, study design, and biostatistical methods.
Biostatistics Services:
- Protocol development
- Provide critical review of CRF and other study materials
- Develop data analysis plan
- Design tables/figures/listings
- Model and analyze study data for abstracts and manuscripts
- Provide the following analysis:
- ad-hoc and special requests
- safety
- marketing
- health economic
Requests for Analyses:
If you would like to submit a request to receive a cost estimate and timeline for Heptronik to perform ad hoc analyses, or to be contacted please click here should take to info@heptronik.com
Dynamic Skill Management
Dynamic Skill Management (DSM) is a new option in your search for development and implementation needs. Customizable and modular by design, DSM can assemble a complete project team in any clinical specialty; then ramp-up the team around a project manager that directs and monitors the team’s daily activities.
By “outsourcing” the legwork of team assembly and maintenance to DSM, sponsors enjoy the benefits of outsourcing while preserving complete internal oversight. From one Biostatistician contractor to an entire monitoring team, DRM can deliver true flexible support.
Support DSM:
Combining the expertise and infrastructure of a national-scale clinical staffing company, along with a managed approach to aligning talent resources, DSM delivers the following trial solutions:
Study “sourcing”: DSM supplies flexible, contracted project teams on-site and integrated around sponsor’s existing infrastructure and project managers for most any clinical trial specialty, across the U.S.
Virtual Consultants Group: For situations where it makes more sense, DSM can assemble an off- site team managed by 1 on-site Project Manager. Monitoring and Medical Writing functions are especially well served in this model..
Domain Skill Group: Outsource a domain or part of an ongoing clinical trial to supplement gaps in support, for example have DSM take responsibility for supplying all the monitors for a study, or all the clinical data analysts..
Project Recovery Group:For situations where outsourced projects need to be pulled back in- house, DSM can create and deploy the manpower needed to help the sponsor recover the trial and complete the project on their terms.
Flexible, Customizable, Modular:
The DSM model can be molded to provide various types of solutions and levels of support, can fit within existing infrastructures and is easily scalable.
Support for Emerging Biotechs & Big Pharma:
Our well-established client network has relied on HepTronik for supporting key projects with critical talent who excel and stand out among their peers. To discuss how you can secure a managed flow of outside clinical manpower while retaining total control over your mission-critical projects.
Validation Services
Since 2004, HepTronik has provided real-world experience in the GLP, GCP, and GMP environments, working with Computer Systems, Automation, and Facilities/Utilities/validation for our many clients. Our experience in Pharmaceutical, with a focus on compliance, quality, and validation. We offer a variety of Validation Services to Life Sciences clients including:
- Big Pharma
- Specialty
- Biotech
- Device
- Generic
We employ Validation, Quality, Project Management, and Operations; and, with an our scientists, engineers, pharmacists, and PhDs are respected throughout the industry for their knowledge and expertise.
Computer Systems Validation:
HepTronik has performed computer system validation since our inception in 2004. Our methodology is easily adaptable and interchangeable with current industry standards such as GAMP4, PDA and proprietary corporate policies no matter the size of your organization. Whatever your validation needs – outlining a validation plan, writing test scripts, developing a comprehensive system validation or managing an enterprise-wide program – HepTronik has the flexibility, resources, and expertise to deliver a higher quality solution.
Validation: Computer Systems Validation (CSV) has become a major area of investment as well as ongoing discussion in the regulated industries. Many users and developers believe that the validation process adds a significant overhead and contributes minimally to the quality of the system and the integrity of its data. The most common cause for poor CSV efforts is the inefficient execution of CSV projects because of varying interpretations of regulatory requirements that focus attention on the style and format of CSV documentation, rather than the ultimate quality of the system.
In light of FDA’s evolving views regarding the value of implementing risk-based approaches , organizations now have the opportunity to reevaluate, improve, and optimize their system life cycle (SLC) and validation methodologies and thus produce better systems more effectively and more efficiently, while ensuring patient safety, data integrity and regulatory compliance.
How HepTronik Can Help : HepTronik’s computer system validation and 21 CFR Part 11 services formally incorporate a business process-driven, risk-based approach to compliance as an integral part of the SLC to ensure compliance with regulatory requirements. HepTronik consultants have expertise in regulatory requirements, CSV methodologies, the technical aspects of computer system development, and the surrounding business processes. The team’s comprehensive knowledge and experience are essential for effective and efficient scaling and execution of CSV activities. Our senior consultants are experts in managing and coaching developers, users, and validation teams to ensure successful conclusion of system implementation and validation efforts. HepTronik’s CSV services cover the full system life cycle, from requirements analysis through system retirement, and are fully integrated with complementary business and regulatory compliance services.
Solutions
Whether your business sells products or provides services, you can no doubt benefit from knowing more about your customers and their opinion about your new or existing offerings. Heptronik in the market research and clinical trial industry have developed a wide variety of processes to collect and analyze any data that may be relevant to your business. While gaining a better understanding of your customers is a constant challenge, finding the right the market research firm to assist you can be an equally daunting task. This is where Heptronik can help.
Heptronik is the leading provider of market research and Clinical trial services. We specialize in connecting pharmaceutical business to target market research by utilizing our extensive expertise. Regardless of the size of your company, Heptronik can assist you in combining in-depth domain expertise, sophisticated analytics and world-class technology to deliver measurable and actionable results that significantly improve the performance of brand portfolios and pharmaceutical sales forces.
We offer best in class practices in:
- Clinical trial design, implementation, analysis and reporting
- Clinical data management and statistical analysis
We welcome your suggestions and encourage you to pursue our entire line of market/clinical research capabilities.
Specialty Market Research
We provide global solutions in sales and marketing tracking, analysis and planning as well as fast-turnaround market research services. Our web-based solutions provide a collaborative environment, enabling our global customers to execute efficient and focused sales and marketing programs. Our unique tools and methodologies align tactics with strategy; facilitating faster and more transparent implementation of optimal strategies.
Customers leverage our solutions and services to:
- Characterize and enhance their sales and marketing development processes
- Install common Key Performance Indicators and metrics to enable tracking and planning across brands and geographies
- Perform strategic and tactical planning, resource optimization and market driven forecasting
- Perform analysis on a wide variety of data to determine the effectiveness of sales and marketing
- Restore visibility for sales and marketing executives, facilitating rapid action and strategy deployment
- Enable ROI driven multi-channel planning of promotional activities
- Characterize and improve physician access and relationships
- Perform high quality, rapid-turnaround market research across the drug lifecycle to answer critical sales and marketing questions
- Perform end-to-end commercialization of brands in specialty pharmaceutical
Advanced Clinical Research
More than 80,000 clinical trials alone are conducted in the United States per year and about 95% of them are still paper-based. So it is not surprising that as life sciences organizations seek ways to drive efficiency and improve performance, one of the areas most closely scrutinized is the clinical development process. Although technological developments have enabled life sciences organizations to gather, process, and communicate clinical trial information more quickly, most of the information technology investments have been in point solutions, applications that address requirements to a particular point in the process. In other words, companies have simply adapted their existing systems to meet the new challenges rather than revising the clinical process as a whole. As a result, some organizations may have between 25 and 30 software applications requiring integration, support, and maintenance.
Data collection and management currently account for up to 60% of the overall clinical trial process, a timeline that drug companies increasingly find unacceptable as they face increasing pressures to test, approve, and market new drugs faster than ever before. Introducing an integrated content management solution to automate the documentation process relevant to clinical trials and related activities can help cut the time for these trials by two-thirds.
HepTronik Clinical Trials streamlines the clinical trial process by capturing, authoring, processing, and managing clinical documentation. By standardizing, controlling, and securing clinical trials-related content, HepTronik Clinical Trials reduces the costs of data acquisition and clean up during trials, enables real-time decision-making based on immediately accessible data, and ensures regulatory compliance and faster submission preparation.
Clinical trial operations management has relied on an inefficient combination of manual paper-based procedures and a variety of non-descriptive and in-housed developed software applications. Typically, software applications were implemented as self-contained, point solutions with little in the way of design considerations for integration with other applications or business processes that are traversed functional areas. More generic product means more competition in off patent market. More competition in off-patent market means more low-price products. More low-price products in off-patent market mean more resources for innovative products.
More innovative products to be generated mean early identification for candidate for drug research.
Therefore the issues mentioned above puts a great importance for quick turnaround of the studies, to prudently use the financial and human resources without repeating to do the same things again and again.
The use of electronic data interchange and the internet as an effective and secure mechanism for data transportation, information sharing, and collaboration have been achieved across number of critical financial and manufacturing sectors with a velocity that suggests it safe for the clinical trial entities to move aggressively, effectively and more forcefully.
Customers leverage our solutions and services to:
- The concept is to synchronize process and increase automation across islands of information, providing systemic improvements to R & D process
- Cross – functional, a holistic process approach, in-depth domain approach, knowledge leverage the use of technology
- Accelerated clinical trials, anyone can create a great looking web-enabled CRF quickly and easily with one-button click to deploy. The back-end engine of business intelligence takes care of the rest. No coding, no waiting, just action results
- It is easy, fast and real-time. eXcileCR streamlines the clinical trial process by capturing, authoring, processing, and managing Trial Master File and high-volume Case Report Form documentation. Rapid implementation gets you started immediately to reap the benefits sooner
- Harvest clinical data to improve early decision-making, early access to the information
- Monitor trends in promotional impact market research and safety, efficacy of new compounds in clinical trials
- Distribution real-time information and educate all concerned stakeholders, participants utilizing a customized web-portal
- Establish global standards for conducting research and exchanging information
Faster approval times, more drugs in the pipeline and drug development costs managed more effectively - Minimized noncompliance risks
Thought Leader Evaluation
Heptronik can help you maximize the brand awareness benefit you derive from your “Thought Leaders”. While these individuals are well respected and knowledgeable, you are making a significant investment in identifying, training and promoting them. You want to make sure the thought leaders satisfactorily deliver to your audience an increased awareness of your brand and its proper use. Heptronik can help you evaluate the effectiveness of speakers in terms of their peer audience and their own prescribing habits. We can help assess whether or not peer to peer programs are increasing appropriate drug utilization and sales. The analyses we provide are easy to understand and presented in an actionable format.
As the head of the marketing and sales in a Pharmaceutical organization, one of the tasks is to have a system in place, which will help to track and perform Return on Investment Analysis (ROI) for multi-channel promotion. This system will allow the Medical Science Associate (MSA) and Territory Reps. to record all promotional, contact, rating, tier and ranking information electronically and automatically generate reports/charts based on different search criteria.
The system is a web-based application, which will allow the Territory Reps. and the Medical Science Associate to enter attendee information, ASO/CSO, Program evaluation and create various reports and charts. For the reasons of security and auditing, MSA and Territory Reps .can only access and edit their own Territory and Program Evaluations.
The system will retain information of all the Key thought leaders identified by your Company. The system will also retain information on all the MSA and Territory Reps. in the company who need access to the system.
The MSA and Territory Reps. will update the physician contacts and the details on a weekly/fortnightly basis. The data Rx for the Key thought leaders has been made available for the MSA and Territory Reps. to see the percentage increase or decrease after any promotional event. This system can keep track of the events, associated cost and the changes in the Rx information. (6-12 months of Rx data to be made available through any data-mart).
The most requested feature of the system is the physician and product wise promotion and cost reporting. Also based on the levels in the company the mangers will be able query the system for different kinds of reports.
There are few standard reports, which have to be calculated offline and integrated into system every month. To calculate these reports fresh data feeds have to be loaded. The system is being designed so that the reports, data load will always be generated automatically and there will be no need for any manual intervention.
The Promotional Analysis reports needs offline analysis and it will be made available as non-editable PDF files. Any search results can be downloaded in to the following formats (PDF, CSV, excel) for further analysis.
Customers leverage our solutions and services to:
- Characterize and enhance their sales and marketing development processes
- Perform strategic and tactical planning, resource optimization and market driven forecasting
- Perform analysis on a wide variety of data to determine the effectiveness of promotional activities
- Enable ROI driven multi-channel planning of promotional activities
- Characterize and improve physician access and relationships
- Ability to take informed decisions for developing marketing strategy
- Better use of NRx and TRx data for effective communication
- Focus on important issues in a timely and organized fashion
- DM and RM can do an audit and generate reports of reps. giving more transparency and accountability in the process flow
- Access to the application from virtually any desktop
Statistical Programming Services
Heptronik’s programmers have a wide array of experience including SAS®, ASP.NET, VB.NET, Java, HTML, ASP, Active-X, XML, SQL, and other integrated languages. Heptronik’s programming staff works closely with the Sponsor, Biostatistics, Clinical Data Operations, Clinical Program Management, and Customer Support Services personnel to produce consistent, high-quality results. Our programmers generate and maintain all code for statistical analyses of clinical data, safety summaries, and health economic projects.
Heptronik’s programmers perform blinded dual analysis to ensure maximum accuracy. Heptronik’s statistical programmers/Data Management team also provide input into CRF design, annotation of CRFs, Clinical Data Operations Guidelines, data analysis plans, narratives, and clinical study reports
Programming Services
- Design of presentation-ready reports with graphics
- Generation of automated data reports
- Programming of special requests and analyses
- Data transfers
- Generation of site payments
Requests for Custom Programming
If you would like to submit a request to receive a cost estimate and timeline for Heptronik’s to perform custom programming, or to be contacted please click here should take to
Biostatistics
Heptronik’s biostatisticians provide their clients statistical computing support, with expertise in areas of statistical inference, regression analysis, multivariate methods, applied probability models, sampling techniques, study design, and biostatistical methods.
Biostatistics Services:
- Protocol development
- Provide critical review of CRF and other study materials
- Develop data analysis plan
- Design tables/figures/listings
- Model and analyze study data for abstracts and manuscripts
- Provide the following analysis:
- ad-hoc and special requests
- safety
- marketing
- health economic
Requests for Analyses:
If you would like to submit a request to receive a cost estimate and timeline for Heptronik to perform ad hoc analyses, or to be contacted please click here should take to info@heptronik.com
Dynamic Skill Management
Dynamic Skill Management (DSM) is a new option in your search for development and implementation needs. Customizable and modular by design, DSM can assemble a complete project team in any clinical specialty; then ramp-up the team around a project manager that directs and monitors the team’s daily activities.
By “outsourcing” the legwork of team assembly and maintenance to DSM, sponsors enjoy the benefits of outsourcing while preserving complete internal oversight. From one Biostatistician contractor to an entire monitoring team, DRM can deliver true flexible support.
Support DSM:
Combining the expertise and infrastructure of a national-scale clinical staffing company, along with a managed approach to aligning talent resources, DSM delivers the following trial solutions:
Study “sourcing”: DSM supplies flexible, contracted project teams on-site and integrated around sponsor’s existing infrastructure and project managers for most any clinical trial specialty, across the U.S.
Virtual Consultants Group: For situations where it makes more sense, DSM can assemble an off- site team managed by 1 on-site Project Manager. Monitoring and Medical Writing functions are especially well served in this model..
Domain Skill Group: Outsource a domain or part of an ongoing clinical trial to supplement gaps in support, for example have DSM take responsibility for supplying all the monitors for a study, or all the clinical data analysts..
Project Recovery Group:For situations where outsourced projects need to be pulled back in- house, DSM can create and deploy the manpower needed to help the sponsor recover the trial and complete the project on their terms.
Flexible, Customizable, Modular:
The DSM model can be molded to provide various types of solutions and levels of support, can fit within existing infrastructures and is easily scalable.
Support for Emerging Biotechs & Big Pharma:
Our well-established client network has relied on HepTronik for supporting key projects with critical talent who excel and stand out among their peers. To discuss how you can secure a managed flow of outside clinical manpower while retaining total control over your mission-critical projects.
Validation Services
Since 2004, HepTronik has provided real-world experience in the GLP, GCP, and GMP environments, working with Computer Systems, Automation, and Facilities/Utilities/validation for our many clients. Our experience in Pharmaceutical, with a focus on compliance, quality, and validation. We offer a variety of Validation Services to Life Sciences clients including:
- Big Pharma
- Specialty
- Biotech
- Device
- Generic
We employ Validation, Quality, Project Management, and Operations; and, with an our scientists, engineers, pharmacists, and PhDs are respected throughout the industry for their knowledge and expertise.
Computer Systems Validation:
HepTronik has performed computer system validation since our inception in 2004. Our methodology is easily adaptable and interchangeable with current industry standards such as GAMP4, PDA and proprietary corporate policies no matter the size of your organization. Whatever your validation needs – outlining a validation plan, writing test scripts, developing a comprehensive system validation or managing an enterprise-wide program – HepTronik has the flexibility, resources, and expertise to deliver a higher quality solution.
Validation: Computer Systems Validation (CSV) has become a major area of investment as well as ongoing discussion in the regulated industries. Many users and developers believe that the validation process adds a significant overhead and contributes minimally to the quality of the system and the integrity of its data. The most common cause for poor CSV efforts is the inefficient execution of CSV projects because of varying interpretations of regulatory requirements that focus attention on the style and format of CSV documentation, rather than the ultimate quality of the system.
In light of FDA’s evolving views regarding the value of implementing risk-based approaches , organizations now have the opportunity to reevaluate, improve, and optimize their system life cycle (SLC) and validation methodologies and thus produce better systems more effectively and more efficiently, while ensuring patient safety, data integrity and regulatory compliance.
How HepTronik Can Help : HepTronik’s computer system validation and 21 CFR Part 11 services formally incorporate a business process-driven, risk-based approach to compliance as an integral part of the SLC to ensure compliance with regulatory requirements. HepTronik consultants have expertise in regulatory requirements, CSV methodologies, the technical aspects of computer system development, and the surrounding business processes. The team’s comprehensive knowledge and experience are essential for effective and efficient scaling and execution of CSV activities. Our senior consultants are experts in managing and coaching developers, users, and validation teams to ensure successful conclusion of system implementation and validation efforts. HepTronik’s CSV services cover the full system life cycle, from requirements analysis through system retirement, and are fully integrated with complementary business and regulatory compliance services.