PUBLICATIONS & WHITE PAPERS
BMK Secure Solutions Secure IT White Paper
Architecture and Development of the DISA Med COI Service
Written By: Erik Scheirer
Abstract: The design, architecture, and implementation of an enterprise-grade integration and authentication platform is a highly complex undertaking, from provisioning and authentication to ongoing maintenance and systems and software integration; often, such ‘integration and authentication’ systems are regarded as simple, and easy to cobble together using off-the-shelf components. But they tend to be nothing simple or easy because there are many moving parts, all of which must be kept robust, maintainable, and secure; many systemic components can be disparate and as such require sophisticated handling in order to be able to interleave the components correctly. There are, however, novel methodologies and techniques available in the industry and in our experience that make such systems manageable and within reach of a small team of technical staff.
"While no single or combined approach can solve all the technical and managerial problems which often plague projects; there is wisdom, experience, and cutting-edge practices to be leveraged to affect minimized project cost and team size while building trust with the participating groups and users by continually delivering the much customer desired on-time, relevant, and accurate functionality and capabilities. The careful attention paid by BMK Consultants & Team of SME’s to the exact technical architecture and the management and engineering processes the architecture affords can achieve this effect."
Read the Entire Article Here
Journal of Medical Practice Articles
"How Clinical Research Can Grow a Medical Practice” Written By: Ashley Nichole Kee
Abstract: Clinical research investigators can use many different tools available to them through their practice and the study sponsor to ensure that they are active enrolling clinical research sites, such as study-specific Web sites, dedicated information lines, and educational sessions. If these tools are approved by the study sponsor and used properly through outreach in conjunction with proper processes and internal controls, a clinical research study will facilitate growth within a medical practice while ensuring that the investigators become or continue to be key opinion leaders within their specialty.
“There are many creative ways to recruit patients into a study. Before beginning any recruitment outreach campaign, get the research study sponsor and institutional review board’s approval to ensure that your recruitment materials are in compliance with all FDA regulations.” Excerpts “Sponsors search and seek out investigators and research departments that can provide high enrollment and quality data.”
“The active enrolling study site is using the clinical research study as a vehicle to grow its practice.”
“A study investigator has many things within his or her control that have a direct impact on the site’s study enrollment rate.”
“Standard Operating Procedures for Clinical Research Departments” Written By: Ashley Nichole Kee
Abstract: A set of standard operating procedures (SOPs) provides a clinical research department with clear roles, responsibilities, and processes to ensure compliance, accuracy, and timeliness of data. SOPs also serve as a standardized training program for new employees. A practice may have an employee that can assist in the development of SOPs. There are also consultants that specialize in working with a practice to develop and write practice-specific SOPs. Making SOPs a priority will save a practice time and money in the long run and make the research practice more attractive to corporate study sponsors.
“Creating SOPs for the clinical research staff provides written guidance and training for investigator and staff.”
“Investigator Responsibilities for Clinical Research Studies: Proper Staffing Can Ensure an Investigator Is Compliant”
Written By: Ashley Nichole Kee
Abstract: The Code of Federal Regulations states that a clinical research investigator is responsible for conducting clinical research in compliance with the signed agreement, investigational plan, and U.S. Food and Drug Administration regulations. In order to meet all the research requirements, the proper research staff is critical. A dedicated, experienced clinical research coordinator is key. The research coordinator represents the investigator when interfacing with the corporate sponsor of the study and the practice staff to ensure that subjects are qualified and that the protocol is followed. Due to the wide range of responsibilities that a clinical research coordinator has, there are three skills that a quality research coordinator must possess: attention to detail, organizational and process understanding, and confidence.
“A clinical research coordinator is the cornerstone to an investigator’s clinical research”
“Lack of confidence should be considered a deal breaker for the position of clinical research coordinator. The coordinator is the face of the practice to the sponsor.”
“An investigator relies on a clinical research coordinator’s ability to be detail-oriented. All protocol deviations are reported to all active research sites and the FDA for review. Minimizing deviations is important to the integrity of data.”