Cassini Biopharma Solutions

Overview


P harma and biotech is one of the most competitive and complex businesses. Long R&D cycles, complex manufacturing processes, intricate supply chains and stringent compliance requirements leave very little room for failures. Biopharmaceutical companies face an increasingly complex environment. Business imperatives for stronger drug development pipelines and improved operational efficiency are driving innovation and technology within the IT sector. Additionally, new genomics technologies as well as other high-throughput technologies present enormous informational, strategic and organizational challenges. How biopharm companies embrace these new technologies could make a crucial difference in their success and well-being.

The biopharma industry is examining how technology can affect or transform existing business processes, particularly drug discovery and development and sales and marketing, the two processes most important to the industry today. Data capture, mining and reporting for clinical trials and e-detailing and e-sampling for sales and marketing are a few of the initiatives that could impact the industry.
- Gartner Research

Unlike most products, drugs have a lengthy, closely regulated, and complex developmental pre-marketing phase usually lasting a decade or longer. During this period of scale up toward commercialization, drugs are influenced by an extremely diverse group of customers and stakeholders, each of which can dramatically alter the conditions of access, utilization, pricing, and sales. And unlike most other products, pharmaceuticals are treated as a public good, usually financed by governments or third-party entities. This is reinforced by global, regional, and national intellectual property laws which frequently determine the timing and impact of generic competition in the product's later years. Consequently, applying the limited LCM approach to pharmaceutical products can lead to flawed assumptions, unrealistic strategies, and value-destroying execution. True product lifecycle in the pharma and biotech industry captures all the phases of the product as shown below.



PHASE 1: Discovery and preclinical trials

This is the phase where a new drug discovery and preclinical trials are done. Scientist and researchers spend a lot of time understand the disease and either create a new molecule or start with an existing one. And for preclinical trials extensive tests are performed to determine if the new drug is safe enough for human testing.

PHASE 2: Get approval from relevant authorities

Once the preclinical trials are complete, next step is to get regulatory approval for actual human testing. The regulatory board will review all preclinical data and plans for clinical testing to determine if the new drug is safe for human testing.


PHASE 3: Different phases of clinical trials

After regulatory approval, the new drug moves into actual human trials where the effectiveness and side effects of the new drug are studied. First tests are conducted in small group of healthy volunteers, then moving into larger groups of patients. The results are then reviewed by the regulatory body for approval of commercial production.

PHASE 4: Large scale manufacturing of the new drug

This phase starts with the manufacture of Active Pharmaceutical Ingredient (API), often outsourced, then the formulation process which involves blending, granulation drying, compaction and coating leading up to and including the production of the tablet, and finally the packaging and labeling of the final product.

PHASE 5: Making sure new drugs comply with specs and standards

Samples from manufacturing process are sent to the lab for quality check to make sure they comply with the specs and detect any deviations for corrective action. This is a very crucial phase of the entire process.


PHASE 6: Support and end-of-life

Once the new drug is released to the market, it needs to be supported and serviced. If there are any issues found after the release, the drug needs to be shelved and recalled. This phase also deals with phasing out the drug.



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Cassini Systems' biopharma solution offers a suite of applications to manage all the above phases of drug development. With our solution you can improve cross functional collaboration, securely manage all your documents, streamline your processes, coordinate your operations with suppliers, identify and mitigate risks, improve your product quality and effectively support and service your customers.

Relevant Products


Cassini Systems offers a suite of applications to tackle the challenges of today's biopharma companies.


Cassini.RX

An end-to-end lifecyle management solution to manage all aspects of your product develoment.
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Cassini.DM

A comprehensive document management solution with built-in workflow engine to securely manage all documents.
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Cassini.WM

A robust workflow management solution to automate your business processes, operations as well as day-to-day tasks.
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Cassini.PS

A people solution to effectively manage your teams. Includes an extensive communication and collaboration tools.
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Relevant Services


We offer a number of services that complement our products to get the most out of your investment. Following are some of the services relevant for infrastructure.


Business Analysis

We offer this services to do a deep analysis of your processes and practices and make recommendations to improve them with best practices and relevant solutions.
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Data Migration

If you are currently using a legacy system to manage your data, we can migrate all that data to our system so that you can be up and running quickly.
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System Integration

If your business uses other IT solutions, we can easily integrate them with ours so that they can work seamlessly. We offer system, application and process level integrations.
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Configuration & Customization

Your business process may have unique requirements that require special configuration and customization. Our skilled professionals can take of those needs.
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