If you are a drug or device company, there are multiple opportunities for partnering with CCC.

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Training and Testing

Off-the-Shelf Content

We can serve as your primary educator or supplement your existing training and testing programs. Our content library covers 5 disciplines: Advertising/Promotion, Promotional Education, Patient Relationship Marketing, Public Relations, and Internet Promotion & Social Media.

Choose from 15 hours of content and more than 500 certification test questions and answers. Our Train + Test system addresses government requirements, legal sanctions for violations, and examples of proper and improper practices.

All content is validated by former FDA officials. Moreover, content for our Train + Test system has been reviewed by major drug and device drug companies; the consensus is that we offer all the basic information needed to promote products in a regulated environment.

The standard course is composed of 3 one-hour modules: regulatory environment, tactical execution, and expert discussion (Q&A). Mini-modules for spot training are also available on specific regulatory topics to meet specialized needs.

Certification tests are developed by a Harvard PhD. Questions are at a reasonable level of difficulty to confirm mastery. They are either multiple choice or True/False; the advanced questions address multi-factorial scenarios

Customized Content

Our customization process is simple: We give you the scripts for our off-the-shelf training in MS Word or .pdf format for your review and editing. The script is then recorded. Based on the extent of changes, we may need to revise the certification test questions, or create new ones.

We can also custom-develop tests to confirm mastery over your existing content.

A number of clients have used CCC to provide training + testing on their internal regulatory compliance SOPs and on company-specific compliance policies. We can provide that in separate modules or combine your information with our standard off-the-shelf content.

Reporting

CCC Reporting

CCC's education technology captures all training and testing data for review and record-keeping. Participation reports can be as detailed as desired, including by individual, by department, by brand, or by test questions that were missed. Weekly, monthly, quarterly, and yearly reports are also available. Reports can also be provided anonymously and in aggregate.

CCC's reports on training participation and testing are useful for supervisory assessment of employees and monitoring of their progress. Reports are designed to help management determine what employees know and to what degree. They enable supervisors to inform employees, on an individual basis, about their knowledge gaps in order to help each person set goals for improvement and regulatory knowledge mastery. In the event of poor performance evaluations, such reports can be used to objectively document an employee's failure to achieve basic competency levels in support of disciplinary action.

Tracking of Your Promotional Agencies

Click here to determine whether your promotional agencies-of-record are staffed with compliance-qualified account team members. If not, you might consider asking them to train and test with CCC.

Additionally, companies can track online their promotional agencies' participation in internal regulatory compliance training using a private outsourcing program.

Monitoring whether mandated educational requirements have been met by your vendors can be time–consuming, because of the number of agencies often contracted to execute drug or device promotion. In addition, the high employee turnover rate at promotional agencies makes monitoring of their compliance education status quite labor-intensive, draining company resources. All of these factors make compliance with a CIA on this score difficult.

CCC's solution: we can do this for you on an outsource basis, using tracking technology we already have in place. Companies simply upload their current training materials (and tests, if there are any) to a privately branded micro-site residing on CCC's website. This private site is then connected to CCC's existing “backroom” reporting mechanism, which can provide the desired level of reporting depth needed to fulfill your CIA mandate.

Regulatory Support

If you need interim regulatory and legal assistance, our experts, many of whom are former FDA officials, can:

  • Ensure that procedures, SOPs, and work instructions are in place for compliance with government requirements for professional and consumer promotion
  • Facilitate meetings with internal stakeholders to clarify, discuss, and resolve areas of disagreement and provide assessment of associated risk
  • Review materials for investigational or approved products to ensure compliance with FDA regulations and policies, as part of your internal clearance committee review process
  • Act as government liaison for marketed products, including helping you respond to enforcement actions taken by the FDA, and designing corrective action programs
  • Act as regulatory liaison with co-promotion partners regarding promotional activities review

Clients

At their request, our list of industry clients is confidential. However, our industry clients include many of the global top 50 pharma companies, as well as prestigious medical device and biotech companies.