Clearing Phase III trials signifies that a product is more than likely to get FDA approval. And after it gets FDA approval, it can be marketed and sold to patients. Businesses can be built (or acquired). And companies, shareholders, and investors can earn millions of dollars in sales and profits.

However, Phase III approval also brings a growing number of operational and informational challenges, including:

  • Increased volumes of cash, inventory, and orders.
  • Increased reliance on distributed supply chains and (contract) manufacturing processes.
  • Increased regulatory (and shareholder) scrutiny and compliance requirements.
  • Increased need to scale, grow, adapt and expand – while maintaining control, security, and quality.
  • Increased need to efficiently and effectively track materials, complaints, documentation, etc…

In order to achieve substantial and sustainable performance improvements following Phase III approval, Life Sciences companies must look to optimize their workstreams, technologies, strategies, and people.

MAXLife for Life Sciences

Merit Solutions enables Life Sciences organizations to transform their business with MAXLife, a robust and pre-configured Microsoft Dynamics AX solution that is deployed in the cloud using Microsoft Azure. MAXLife consists of pre-built business process models, industry-specific documentation, implementation templates, and integrations with top vendors – creating a preconfigured solution that can be “dropped in” with standard configurations or used as an “accelerator” for global deployments.

Learn more about MAXLife for Life Sciences.

Why Merit Solutions

Merit Solutions has extensive experience partnering with pre-commercial and rapidly growing biotech and pharmaceutical companies to enable a smooth transition and successful launch to market once they’ve been approved. We enable these companies to streamline processes and implement compliant, integrated, and validated solutions for ERP, Quality Management, Document Management, Mobility, and more! 

Through our industry-tested combination of front end process consultants, back end technology practitioners, and industry Subject Matter Experts, we have the expertise to help Life Sciences companies manage risk, ensure operating performance, maintain compliance, and pursue global growth opportunities. Our broad range of Life Sciences consulting services and IT solutions help address the challenges related to traditional processes, cultural resistance to change, and less scalable technologies – enabling successful improvement projects while operating in a globally regulated environment.

Rapidly growing organizations and those expecting Phase III approval typically experience the following results from partnering with Merit Solutions for success:

  • Speed Implementations and Time to Value – Benefit from pre-configured, industry-tested workflows and software solutions that drastically reduce the cost, time and implementation effort – from those that want an out-of-the-box cloud solution to those with more complex and global requirements.
  • Increased Ability to Rapidly Scale – When you grow, you have increased volumes going through your business work streams, and increased variations in those work streams coming from different types of customers, order, products, suppliers, and partners. Merit will help you remove the disorganization potential of paper-based and manual work streams, eliminating risk and impediments to your rapidly growing company.
  • Faster Innovation and Reduced Cycle Times – Significant increases in the volume and complexity of internal and external business data provide growing challenges when locating, retrieving, sharing, processing, and distributing that information. We help companies enforce the consistent execution of processes while providing an accurate, real-time view of critical data to those who need it.
  • Improved Decision Making – Merit helps clients eliminate the time delay in getting accurate, consistent, and usable information that comes from manual and paper-based processes. By implementing work streams and information flows that connect your activities in the most efficient manner for delivering customer value, we are also enabling real-time access to the most important information the company needs for business decision making.
  • Reduced Compliance Costs – Merit Solutions helps Life Sciences companies define a compliance strategy, designing the preventative, data integrity, and significant process controls required to carry out and efficiently operate your enterprise compliance strategy. Along with our partners, we help clients deploy validated systems that have effective change management built in to support the changing needs of your company moving forward.
  • Reduced Operating Costs – The biggest cost of manual processes is people. It costs companies time (money) by manually performing tasks that can and should be automated and streamlined. Automated systems and processes also reduce the risk of human errors, which can result in redundant processes, rework, or even audits. And the eliminate the large costs associated with printing, reviewing, storing and retrieving paper documents.

Merit Solutions helps our life sciences clients drive their business, process, and enabling systems changes required to achieve their strategic vision and goals. This includes everything from future state business process mapping to systems analysis, fit-gap process definition and scoping, sourcing, design and deployment, integration with other systems, on-going support, and systems validation.