Bloomedha Info Solutions: Sustaining Pharmaceuticals in Clinical Research and Compliance
India is witnessing a robust growth in the clinical research landscape with advanced technological solutions acting as the main catalyst. The industry boasts of a diverse patient pool, qualified medical professionals, massive population in need of medical treatment, data specialists, and good regulatory policies. The introduction of technology offers access to better patient data that complements existing sources. Additionally, it also offers an improved understanding of the progression of a particular disease and response to the therapy applied. However, providing solutions for a regulated industry like Clinical Research and Pharma is very challenging as one requires striking and maintaining the perfect balance between a broad spectrum of entities; technical know-how, domain knowledge, solution adaptability, integration challenges, country-specific regulatory requirements and affordability ranking the topmost. Attaining the right balance with the required technical prowess is Hyderabad located Bloomedha Info Solutions. The company works closely with enterprises in Clinical Research in providing a solution with a unified platform for all the stakeholders while ensuring data integrity and business continuity. The comprehensive suite of innovative and user-friendly solutions is configurable and highly scalable by design, thereby making the transition to changing regulatory requirements easier. The novel platform is seamlessly integrated with reports for regulatory authorities and it displays information about subject-study participation, Adverse Events (AE) and Serious Adverse Events (SAE). Founded in 2010 and with the core focus of delivering cutting-edge solutions to the Pharmaceutical and Life-Sciences industries, the company provides Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS), Clinical Trial Study (Bio-Equivalence and Bio-Availability -BA/BE) Management Systems, Data Management Services, Laboratory Information Management Systems and Custom Application Development services among a host of other offerings.
Automating the BA/BE Process Workflow
The BA/BE management system, Clinensure, is a compliant and validated E-CRF solution platform. The entire BA/BE process workflow involves a gamut of departments that could be geographically scattered across the globe but will have to work closely with each other for the final regulatory submission. The solution helps clients take a step back from the conventional methods like utilizing Word Processors and Spread-Sheets to perform various operations.
Delving deeper into the offering, the solution is a complete end-to-end electronic platform that automates the process workflow related to departments involved. This eliminates the probability of errors since the study is process oriented rather than person dependent. The solution ensures faster Turn Around Time (TAT), assured Data integrity and provides a compliant environment for Study/Project delivery under its umbrellas of services. The company states that their offering is the only BA/ BE solution in the market that encompasses the entire workflow right from Volunteer management, Screening, Study protocol definition, PK Sample management, Bio-Analytical and CDISC reporting.
In conjunction with this, the studies conducted with a volunteer participating in the aforementioned BA/BE studies demands a minimum gap between the subsequent studies as per the stated Regulatory guidelines. This is generally advised in order to avoid any compromises in the volunteer’s health and to maintain the integrity of the study being conducted in the event of a Volunteer Cross or Over participation. The impact is multi-fold when it comes to women volunteers because of the impact it might have on pregnancies. Spearheading this predicament, Bloomedha designed and developed a Cloud-based Biometric platform, Sentinel, which assists CROs to recruit only eligible volunteers for the studies. Thus, the solution ensures that the volunteer health status is not compromised and also the set quality bar of the studies being conducted in India is improved. They are also focusing on enabling multi-modal biometrics, where applicable in their solutions, to facilitate and meet the compliance requirements of various regulatory bodies.
Dedicating their industry-rich knowledge towards this market, the team is currently working on a Business Intelligence platform. The company envisions this data enabled the platform to empower the management and operational team to take key business and technical decisions based on the available data. The solution can integrate with various data sources both internal and external to the organization. With the vision to meet and exceed client expectations, the company aims to direct at least 80 percent of the BA/BE Clinical Studies taking place globally to go through the company’s solution by 2025.
The comprehensive suite of innovative and user-friendly solutions is configurable and highly scalable by design, thereby making the transition to changing regulatory requirements easier
In conjunction with this, the studies conducted with a volunteer participating in the aforementioned BA/BE studies demands a minimum gap between the subsequent studies as per the stated Regulatory guidelines. This is generally advised in order to avoid any compromises in the volunteer’s health and to maintain the integrity of the study being conducted in the event of a Volunteer Cross or Over participation. The impact is multi-fold when it comes to women volunteers because of the impact it might have on pregnancies. Spearheading this predicament, Bloomedha designed and developed a Cloud-based Biometric platform, Sentinel, which assists CROs to recruit only eligible volunteers for the studies. Thus, the solution ensures that the volunteer health status is not compromised and also the set quality bar of the studies being conducted in India is improved. They are also focusing on enabling multi-modal biometrics, where applicable in their solutions, to facilitate and meet the compliance requirements of various regulatory bodies.
Dedicating their industry-rich knowledge towards this market, the team is currently working on a Business Intelligence platform. The company envisions this data enabled the platform to empower the management and operational team to take key business and technical decisions based on the available data. The solution can integrate with various data sources both internal and external to the organization. With the vision to meet and exceed client expectations, the company aims to direct at least 80 percent of the BA/BE Clinical Studies taking place globally to go through the company’s solution by 2025.
