Paradigm Shift – Project-based Engagement to SLA/Capacity-based Compliance Outsourcing

Life science companies are still struggling to find the right balance in managing IT compliance, quality and cost. They must meet compliance requirements for multiple regulations, while at the same time are under significant pressure to cut costs, reduce permanent staff, and outsource activities that are not part of their core business. Compliance costs are considered a significant overhead, especially when not done effectively. To optimize these costs while increasing work quality, firms are moving away from project-based engagements to service level agreement (SLA)/capacity-based models.
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Three Questions to Ask Your CMO about Standard Operating Procedures

Developing and implementing standard operating procedures (SOPs) are an important part of drug development and manufacturing. Done correctly, SOPs provide consistency and ensure that procedures meet FDA standards. Done poorly, they can be unclear, leading to errors and inconsistencies and focus on the how but not the why.  A challenge of enforcing quality SOPs is that information can become quickly outdated because of constantly updated FDA regulations.
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Life Science Management Consultants: Looking at the Right Stuff

Envision your contract research organization’s (CRO) team has significantly underestimated the complexity of a large pivotal program in a breakthrough medical treatment for your client, a major medical device company. You, your team, and the entire company are under immense pressure from the FDA because of safety concerns, which have escalated to an excruciating level of tension. You may find your tension level rising just reading this. For many organizations, this scenario is all too familiar, as regulatory and compliance regulations increase.
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Understanding and Successfully Leveraging Management Consultants

Market complexity, the speed of change, downward pressure on margins, increased regulatory oversight, and process and optimization issues are just a few of the market realities that pharma, biotech, and medical device companies are experiencing. So it’s no surprise that specialized expertise is required to navigate and uncover the key areas a company needs to focus on to achieve and maintain profitable growth.

Management consultants exist to provide that expertise and it is important to understand the broad continuum of expertise available and when to utilize each one. The continuum includes strategy consultants, process consultants, regulatory content experts, and implementation resources. Maximizing your investment requires understanding each of these areas of expertise and when use them.

Strategy Consultants  

Strategy consultants are primarily focused on where the company should be going and in how the organization will get there. Strategy consultants are good at providing direction, uncovering market opportunities, and designing competitive advantage into an organization. They can help provide market and competitive research that determine the decision making framework for senior leadership.

Strategy consultants usually have a great deal of experience in specific market segments and bring a wealth of market and competitive knowledge to the table.

When your organization needs to make decisions about pricing strategy, opening international markets, or mergers and acquisitions, strategy consultants are your go-to resource.

Process Consultants

Process consultants are primarily focused on the how of execution. Their expertise covers a wide variety of industry independent issues including planning, hiring, resource management, workflow processes, decision making, risk mitigation, project management, leadership training, and many others. Perhaps the largest portion of the continuum, the process consultant is focused on delivering improved performance and effectiveness in the organization’s operations.

Process consultants range from operational strategists who work on overall integration and effectiveness to specialists who focus specifically on talent acquisition, sales training, marketing, or succession planning. Process consultants usually work across verticals and bring a wealth of experience in their chosen discipline rather than in a specific vertical market.

Regulatory Content Experts

Regulatory content experts are just that; content experts in very specific and well regulated fields like banking, oil and gas, pharma, and bio-tech. They bring very specialized knowledge of the vertical, the laws and regulations that apply to that vertical, and a clear understanding of the processes and tools required for compliance.

Regulatory content experts often hold very specific certifications and have invested years of their careers in the industry; often as regulators, lobbyists, or in senior staff roles.

Implementation Resources

Implementation resources are experts who help you build the systems, IT or otherwise, that are necessary to executing specific initiatives whether driven by strategy, operational considerations, or regulatory demands. They often take the form of IT consultants helping to build middleware and construction experts that build new labs to exacting specifications. I also include trainers in this category since once they complete their work, it is turned over to someone else to operate or run the system.

Key Areas of Focus

Effective execution in a regulated industry of course involves all of the above. From direction, the overall health of the organization’s operations, to regulatory compliance and implementation – each requires attention and expertise. However, in our chaotic economic environment, the following three key areas are becoming more critical and are prime opportunities to leverage the expertise of management consultants.

  1. Culture and communication for commitment. No matter the strategy or the operational systems, successful organizations and teams have a culture of commitment. They keep a high “say/do” ratio. Ensuring that a team, a department, and even a whole company understands the language and processes for increasing commitments is one of the greatest opportunities for making a difference in the organization’s ability to execute.
  2. Explicit agreement and transparent accountability. A culture of commitment is necessary, but it is not sufficient. Organizations also need a method of capturing commitments (Who will do What, for Whom, by When) and of tracking how well the commitments are kept. There is no surer way to increase the “say/do” ratio and resulting trust within the team.
  3. Practical tools for developing people. Organizations must be ever more responsive to customer and marketplace demands and that requires that decisions need to be pushed farther and farther out to the line employees nearest the customers. And while one would hope that everyone would be open to learning and self improvement, it doesn’t happen by default. The culture of an organization and the proper tools can go a long way to making that true. Deploying operational basics like coaching (formal and informal), a system of checklists for critical operations, and clear guidelines for what decisions can and cannot be made on the front lines are just a few of the areas where management consultants can be leveraged.

To use management consultants effectively you must:

  • Define your objective in terms of outcomes.
  • Identify that outside expertise required or that will accelerate achieving the outcomes.
  • Recognize the type of consultant needed.
  • Establish how you will measure success.

Only then will you be in the position to choose the right consultant who will work with you to craft an initiative that will help you dramatically improve your key area of focus for a proper return on your investment.

Rethinking the Role of Regulatory in Innovation: Part 2

This is the second in a series of articles on the need to eliminate the misperception that regulatory, legal and compliance professionals are sales suppressors and policemen.   These functions and innovative thinking are not incongruous terms. If you have not yet read how these professionals can (and do) think outside of the proverbial box to support their business colleagues and achieve critical company objectives that help increase the top and bottom line, please click here.
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A “How To” for Recording and Allocating Event Spending

Since the inception of Open Payment, CMS has been seemingly forgiving regarding the accuracy and consistency of submissions. However, this tolerance appears to be dissipating as reporting entities acquire the experience necessary to understand exactly what is expected of them. Perhaps Ms. Mary Riodan from the Office of Inspector General encapsulated the government sentiments best when very recently, she essentially stated: [Read more…]