Narrowed profit margins, patent expiries on profitable drugs and escalating R&D costs have put significant pressure on Life Sciences organizations. The number of new product launches too have taken a hit. The estimated amount of introducing new drugs stands at $2.9 billion on average. There has been a serious amplification in market competition and surging customer expectations. Adding to the predicament, Life Sciences and Pharma companies must also adhere to stringent regulatory standards to improve the efficiency and quality of healthcare. Restoring consumer and investor confidence, and optimizing product portfolio to the patient population have been a top priority for Life Sciences and pharmaceutical firms.

The FDA (Food & Drug Administration) mandates healthcare professionals to provide detailed reports in case of Adverse Drug Reactions (ADR) when administered by a patient. Drug manufacturers need to be compliant with reporting regulations, and must compulsorily monitor the quality of drugs, and report any suspected undesirable effects encountered during the manufacturing process. Any delay in reporting will cause reporting to be inaccurate and unreliable. Drug Manufacturers and Pharma firms are compelled to build a robust reporting system for ADR assessment within their operations and get compliant of safety data.

Element has just the thing,

Great way to Save Costs – A Worry-free way to Ensure Compliance

Element’s collective response to the above underlying challenges is Corporate Adverse Event Reporting & Evaluation System (CARES). With CARES, organizations can benefit from a global validated mission-critical reporting system to perform accurate and timely reporting on adverse events related to manufacturer’s drugs at extremely reduced costs.

Successful deployment – It’s more than just numbers

Our extensive experience in the Life Sciences domain has translated to many successful deployments of our reporting system to leading Life Sciences organizations in more than 170 countries worldwide. We make use of the latest and trending technologies to effectively ensure quality and accuracy of the source data and timely reporting and ensure efficacy is maintained until the very end.

Life Science Business Consulting Services 

Organizations in the life sciences sector are under great strain because of shrinking profit margins, the patent expirations of valuable pharmaceuticals, and rising R & D expenses. Additionally, there have been fewer new product introductions. The average cost of releasing new medications is pegged at $2.9 billion. As a result, the competition in the market has significantly increased, and client demands are rising sharply. To worsen the situation, life sciences and pharmaceutical industries are also required to follow strict regulatory guidelines to enhance healthcare effectiveness and standard. For life sciences and pharmaceutical companies, regaining investor and consumer trust and improving their product offerings for the patient population have been major priorities.

If a patient administers a drug and has an adverse drug reaction (ADR), the FDA (Food & Drug Administration) requires healthcare practitioners to submit thorough reports. Likewise, manufacturers of pharmaceuticals are required to abide by reporting rules, check the quality of their products, and report any potential unfavorable side effects they may have come across throughout the production process. Any reporting lag will result in erroneous and unreliable information. Therefore, pharmaceutical companies and drug manufacturers must develop a reliable reporting system for ADR assessment within their operations and comply with safety data.

Life Sciences Industry Solutions

Organizations may comply with and satisfy evolving regulatory standards with the help of SAS Clinical Services. Increasing productivity and lowering operational expenses are the two goals of the tailored solutions we provide. Element Technologies is one of the best life science consulting firms that uses adaptable and scalable engagement models to manage your SAS programming needs. The certified SAS clinical programmers on our staff are up to speed on all regulatory standards requirements and provide verified clinical research reports and submission-ready deliverables. Element Technologies accomplishes this by complying with CDISC standards and other significant regulatory models, such as the SDTM and ADaM, and ensuring firms keep up to date with the most recent regulatory needs.

Clinical Data Management services adopt best practices to help enterprises adhere to international data standards (CDISC). The availability of accurate and comprehensive data for processing is ensured. There has to be more data aggregation to maintain regulatory compliance. Clinical research expenditures are decreased, and medication development is sped up with more data aggregation and reusability. Element’s Technologies specialised methodology promotes consistency in clinical data management & life sciences industry solutions by assuring standards compliance while preserving data quality and integrity.

Using biostatistical services & life sciences industry solutions, you may evaluate data that is accurate and able to withstand the inspection of regulatory authorities. Throughout the whole clinical development lifecycle, including protocol formulation, trial design, statistical Analysis, and regulatory filing, Element Technologies offers its clients biostatistical, life sciences industry solutions & statistics programming services.

Program management, biostatistics, and clinical SAS programming: 

• Protocol’s statistical input
• Measurement of sample size 
• Randomization
• Mock TLF shells and SAP development
• CSR statistical section writing 
• Reporting on Safety and Efficacy 
• Final Evaluation 
• The PK/PD Analysis
• Analytical Exploration 
• Meta-Analysis
• Dataset for Analysis (specified by ADaM and Sponsor) creation 
• High-quality reporting and Analysis 
• Summary Support with Integrated (ISS/ISE)
• The combining of data 
• Report on Analysis
• Developing applications (SAS Programming) 
• Using SAS Visual Analytics (Authorised SAS partner)
• Support for SAS administration and installation (Authorised SAS partner)

Excellent Way to Reduce Costs – An Uncomplicated Way to Ensure Compliance

The corporate Adverse Event Reporting & Evaluation System is Element’s Technologies reaction to the underlying issues listed above (CARES). Organisations may use CARES, a globally proven mission-critical reporting system, to undertake accurate and prompt reporting on side effects involving manufacturer’s pharmaceuticals at incredibly low costs.

Thanks to our considerable knowledge in the field, we have successfully deployed our reporting system to several top life sciences firms in more than 170 countries. We employ the most recent and popular technology to efficiently guarantee the quality and accuracy of the source data, prompt reporting, and the maintenance of efficacy to the conclusion.

We know that adhering to CDISC and data tabulation & conversion models like SDTM and ADaM is essential for enterprises to comply with regulatory requirements. Therefore, our professionals use the CDISC industry standards to help firms obtain a competitive edge through data standardization. In addition, they have extensive domain expertise in clinical data solutions.

Element Technologies employs qualified personnel to facilitate the interchange of clinical research and meta-data and provide a value-added mix of technology, low-cost worldwide distribution, and industry-wide data standards. In addition, we use scalable best practices of life sciences industry solutions and technologies to allow the consistent provision of high-quality healthcare services, life science business consulting, assist regulatory processes, and standardise data across many therapeutic areas.