This blog discusses latest trends and the role technology plays in the life sciences industry. It focuses on Infosys life sciences services and solutions and how they can help accelerate business.

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May 29, 2014

Clinical Trial Supply Management: A Solution for CROs

Biotech firms of all sizes have come to rely on the specialized services of clinical research organizations (CROs). Doing so is the best way to get their most promising drugs through complicated, multi-tiered trial processes and into the hands of those that need them most: sick patients.

No longer can a single firm attempt to manage these trials without the right suite of solutions. What pharmaceutical companies and CROs alike need are highly effective clinical trial supply management solutions that connect all relevant organizations from beginning to end. Clinical suppliers can instantly relay their status, location, and tracking of information on medications in the supply chain. CTSM solutions involve everything from drug product development, packaging, and distribution to investigational sites, dispensing, inventory, and even return & destruction.

Commercial supply chain solutions lacked the ability to serve the dynamism and flexibility needs of clinical trial supply chains. So, too, have the integration capabilities with interactive response technology and rapid data exchanges needed in the supply chains.

Today's clinical trial supply management solutions are very few. They come with planning & forecasting characteristics, packaging & randomization management, distribution, clinical batch management & country approvals, and analytics. However, a partially pre-configured solution, hosted on a cloud, adds much more than the typical CTSM solutions to the value proposition for smaller but critical entities like CROs. Add to that the wide array of robust Infosys implementation services such as business care preparation, scoping, and business blueprinting.

The readily available documents and accelerators from Infosys include industry business process requirement documents, business process maps, and technical accelerators such as data migration tools, transport management tools, and test automation tools that enhance the time to market significantly and bring CROs on board in three to six months.

To create a seamless experience in the clinical supply chain, an application fostering standardization across data definitions, operating procedures, and data services is the prime need. The CTSM on Cloud by Infosys makes this a reality. Sponsor companies use the same data structures and their contract manufacturers need to align to those standards. That's why an ecosystem of sponsor companies and contract manufacturers continues to grow. Your CRO needs to be a part of this rapidly evolving group.

With an aligned set of data standards, architectural framework, and operating procedures, a robust CTSM solution from Infosys ensures that all companies get high visibility on stocks and the needs of patients. Doing so on a real-time basis allows the CRO to use planning technology that compares planned demands with actual needs and supply chain inventory overcoming the challenges associated with the dynamic nature of demand - supply cycle in clinical trials. It truly suits the need of adaptive trials.

What's key to this new solution is that any process can be happening anywhere on earth - yet the sponsor company knows about every interaction as if it were under its own roof. For example, compliance controls are embedded in processes using technology that considers quality and logistics information. Electronic expiration dating read-outs on Android devices allow companies to control dates by clinical site and patient in more compliant ways.

Consider the Multi-Level Warehouse function. Using an array of scanning tools and barcodes for inventory management, an enterprise can receive the exact location of each medication kit under trial. This highly efficient warehousing operation operates via radio frequency-based scanning transactions. Plus, it's all tied in with SAP's multilevel handling unit for maximum efficiency. Batch numbers are also ties into the SAP software. Specific medication number (serial numbers, really) are given to both supply and replenishment deliveries. Doing so prevents faulty shipments and facilitates returns of unused or expired drugs.

Then there's the question of size. It's not uncommon for some CROs to run thousands of clinical trials for their larger Pharma clients. But there is a growing number of boutique firms and researchers that might only need a handful of test runs. Because the Infosys CTSM solution is scalable, companies receive just-In-time & on-demand solutions for very small trials. CROs can come on board without huge investment and start operating seamlessly with the manufacturers and other entities. It's truly a revolutionary application, bringing Pharma, MROs, CROs, distributors and regulators onto one single platform.

Clinical Trial Supply Management: A Streamliner's Guide

There is a lot to understand in the new and exciting world of Clinical Trial Supply Management. For now let's focus on two major developments:

Virtualization of supply chain information. Large pharmaceutical companies have become reliant on healthy collaborations with contract organizations. These external parties focus on a good portion of the clinical trial supply process. But how does everyone involved ensure that the collaboration is indeed a compliant and efficient one? This is no easy proposition.

In fact, the CTSM solution by Infosys Lodestone helps life sciences enterprises get the kind of competitive advantages they need by leveraging cost savings and heightening productivity.

Big Pharma and medical device companies want to virtualize the information in the supply chain considering the collaboration with contractors. External contractors can update their serialized and lot-related information using Web-enabled technology so that virtualization of a clinical supply chain becomes more end-to-end. All manufacturing & distribution operations as well as clinical sites are all connected using Web access on the sponsor backbone system.

Contract organizations can also put the same Infosys Lodestone CTSM solution in place across their operations. Such an approach can increase the contractor's market share within the niche clinical trial supply market because sponsors will select such vendors for easy and standard integration with their own CTSM backbone. A CTSM solution can be also hosted externally. By that way, a contract organization does't need to internalize an IT department while benefiting from a industry-wide standard solution.



Electronic data instead of paper or labels. The Infosys Lodestone CTSM solution can support strategies to strengthen relationships with investigators or patients, such as providing fingertip access to critical information with easy-to-use productivity tools like smartphones, which make conducting trials less time- and resource-consuming.

Smartphone usage is ubiquitous in new trial regions such as China. These mobile devices are widely used by people of all age groups to communicate in transit as it is more cost efficient to send a text message than to place a call. One of the largest domestic contract research organizations in China has been routinely using texts to send reminder messages to investigators regarding planned site visits, as well as to patients to remind them of scheduled study visits.

This practice is extended for the electronic display of expiration dates by scanning two-dimensional barcodes with a smartphone instead of printed expiration dates on labels. The Infosys Lodestone CTSM solution is enabling such compliant and secure exchange of expiration dates over the Web.

These are just two of many reasons why a Cloud-based clinical trial supply management system is the best solution for enterprises looking to lower drug development costs.

May 19, 2014

 Is Creative Approval Process A Major Bottleneck For Your Marketing Organization?

Most often during the Business Process Re-engineering of an organization, marketing content approval process also commonly referred to as the creative approval process is believed to be one size fits all which results in a dysfunctional process.
A dysfunctional approval process creates unnecessary bureaucratic bottlenecks which hinder creativity, increases time to market and puts organization at risk of digital compliance violations.
Life science organizations where compliance stakes are higher often tend to make the creative approval more complex, rigid and cumbersome, resulting in inefficiencies and ultimately affecting the bottom-line.
A desirable optimum creative approval process should pass four points litmus test;

1-Are creative teams empowered enough to take decisions at early stage?
The creative teams should be empowered enough to understand, business, marketing, regulatory compliance and legal issues so that repetitive mistakes could be avoided and the rate of rejection at approval stage could be capped. For instance setting up a target of an acceptable rate of rejection at approval stage would be effective tool to reduce time to market without compromising on digital compliance guidelines.
This could be achieved by a) training of creative teams b) providing time to time guidelines about regulatory, marketing or legal issues c) involving creative teams in campaign strategy meetings.

2- Is number of approvers optimum?
It is quite common to have a long list of approvers, for any asset which ultimately make approval process a bottleneck, most people on the list happened to be executives who have different reasons to be on list than approving the content.  The way forward is to identify their interests and provide alternative and effective means to address their interests than blocking the approval process.


Classification of executives


For information: Executives who are on approvers list just because they wanted to be informed of assets being published. They should be provided notifications or dashboard tools and should be taken off from approval process. For examples senior executives like CMO, Vice president Marketing, Customer Relationship Director etc.
Reviewers: These types of executive are not of Primary Business or Regulatory compliance/Legal significance, so they should be invited to provide inputs at the creative stage; however their consent should not be mandatory for the process to move ahead.  This ensures that if they do not revert with in the stipulated time the asset can move forward in the process.
In an ideal situation number of optimum reviewers should be;
1. Business Owner
2. Medical
3. Marketing- only in cases where there is a Primary Marketing Significance
4. Regulatory compliance/Legal- only in cases where there is a primary Regulatory/ legal significance.

Approvers: These are Executives with Primary Business or Regulatory compliance /Legal significance and nothing moves out until they say yes. They are signatories to the assets.
In an ideal situation, an optimum list of approvers should include:
1. Business Owner
2. Marketing
3. Regulatory compliance/Legal

3- Are roles and responsibilities defined?
Defining who needs to review what is the key for setting of efficient approval process.  Everybody should not be reviewing the creative concept of a campaign. The Chief Marketing Officer (CMO) should not be micro reviewing each asset published by the department.  Well defined roles and responsibilities ensure that, right text or asset is reviewed, by the right people and at the right time.

4-Is the approval process flexible?
Different assets have different review and approval requirements, so the process should be flexible to accommodate various requirements without compromising on efficiency.  Below matrix could be used as an example of flexible risk based approval;


 

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If answer to any of the above four points is not affirmative, then the creative approval process of that marketing organization could prove be a major bottleneck for growth and success. It may also put the organization at risk of digital compliance violations.  Serious rethinking and professional Re-engineering along the lines of the above mentioned four point framework would help to achieve an efficient creative approval process and ultimately an efficient and compliant marketing organization.

 

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