Outsourcing Your Medical And Scientific Writing Projects

By Thomas A. Burns, Jr., Tekrighter Scientific and Medical Writing Services

Successful competition demands that management simultaneously achieves reduced costs while improving productivity. One tool to attain that goal is outsourcing tasks that fall outside of core business functions.

Scientific writing has been identified as a key function of consideration for outsourcing. (Lele and Rothman, 2011).
Outsourcing your scientific and medical writing projects:

• Allows your personnel to focus on core business needs.
• Increases staff flexibility.
• Increases staff productivity.
• Increases billable hours.
• Allows your company to complete more projects in the same amount of time.

This report summarizes some best practices for outsourcing your scientific and medical writing projects.

What is Outsourcing?
Outsourcing simply means sponsoring someone outside of your company to provide a service that you do not want to assign to internal resources. An outsourced writing project can be as simple as a single document ̵ for example, an article highlighting your company for a trade publication, a poster for a scientific meeting, or an article for a peer-reviewed journal. The project can also be very complex and multi-faceted ̵ for example, a regulatory submission.
Many kinds of scientific and healthcare businesses routinely outsource scientific and medical writing projects. These include:

• Pharmaceutical companies.
• Healthcare product companies.
• Medical device companies.
• Contract Research Organizations.
• Public relations and marketing firms.
• Scientific content and healthcare communication providers.
• Medical Journals.
• Medical or scientific societies.
• Healthcare Websites.

The above list is not all inclusive. Both large and small companies find outsourcing of scientific and medical writing an attractive option.

Outsourcing can be accomplished on-site, with the contractors working in your office and using your equipment, or off-site, at the contractor’s office, or via telecommuting. Which model you choose depends on your preferences, and the nature of the job at hand. For instance, if you are sub-contracting, your contract might require that the subcontractors work on-site.

Do not confuse outsourcing with offshoring. Offshoring refers to moving a business function to another country. Outsourcing can be offshoring, but it also can be done locally, and is often easier and more efficient if accomplished that way.

When to Outsource Scientific and Medical Writing Projects
The most common reason for outsourcing your scientific or medical writing projects is that you need specific expertise that does not reside within your company. Many scientists, while extremely competent in their chosen fields, are simply not good writers. Or you may have people with writing experience on staff, but they may be overtaxed, so they could not be expected to produce additional deliverables in a timely manner.

Large, autonomous projects are often good candidates for outsourcing. Rather than hire new staff to do such work, it can be more convenient and cost-effective to engage a company that already has the necessary personnel to complete the project. Of course, you must designate a project manager on your staff to assume overall responsibility for the project, and you may have to dedicate more of your employees as well, depending on project’s the size and complexity.

However, large, complex projects are not the only good contenders for outsourcing. Often, individual documents, or a group of related documents for a specific project, can be more efficiently produced via outsourcing.

Examples of documents that readily lend themselves to outsourcing include:

• Documents contained in regulatory submissions (e.g., NDAs, sNDA,s ANDAs, BLAs, MAAs, 505(2)(b)).
• Documents contained in Investigational New Drug Applications.
• Investigators Brochures.
• Risk Profiles.
• Study Protocols.
• Clinical reports.
• Articles for peer-reviewed journals.
• Articles for trade publications.
• Posters for scientific meetings.
• Presentations.
• Abstracts.
• Grant proposals.
• Press releases.
• Online content for:
  • Blogs.
  • Company website.

Best Practices for Outsourcing of Scientific and Medical Writing

Hire Responsible, Professional Writers

If you want good work, hire good people. If possible, hire people who have worked for you previously, or who are recommended by someone who you know and trust. A reputable professional staffing firm is a good option if your project is large enough to interest them.

If you must hire someone that you haven’t worked with before, make sure you get references, and check with them. Ask specific questions, such as:

• What was the nature of the work that was done?
• Did the contractors make or miss their deadlines?
• How much editing or revision of the work by in-house staff was required?
• Did the contractor offer concrete suggestions that facilitated completion of the project?
• Was the project completed on time and on budget?

Outsource Locally
Many large companies outsource overseas, to take advantage of lower costs in developing countries. However, this is almost never a good idea unless the outsourced function is ongoing within your company, rather than a project of limited duration. Reasons include:

• Local writers will be native English speakers.
• Local contractors will be familiar with local markets.
• It will be easier to schedule meetings with local contractors.
• Time zones can pose significant scheduling issues.
• Turn -around times for revisions will be quicker.

Communicate, communicate, communicate!
Establish a communication strategy with the contractors before beginning the project. Essentials include:

• Hold a project kick-off meeting with the contractors.
  • Establish a single point of contact within your company and with the contractors.
  • Explain how the contractors’ project fits into the big picture.
  • Clarify what level of participation you expect from the contractors. Ideally, they will be equal partners in the project.
• Include the contractors (or their contact person) in all important meeting and teleconferences concerning the project.
• Remember that project management is ultimately your responsibility. Good project management includes:
  • Writing contracts and the Statement of Work (SOW).
  • Answering contractors’ questions.
  • Dealing with any issues or misunderstandings immediately.
  • Timely revision management, which includes:
    • Quick acknowledgement of receipt of drafts.
    • Return of revisions in a timely fashion.
  • Processing of payments.
• For all but the smallest of projects, provide a written SOW. The SOW should include:
  • A description of the project deliverables. This should include:
    • Intended audience.
    • Length.
    • Specific formats required.
    • Appropriate writers’ guidelines.
  • Significant milestones and deadlines.
  • A description of the revision cycle, including how many revisions will be done for each deliverable.
  • How and when payment will be made.
  • Contact information for project managers and subject matter experts.
• Set realistic deadlines. Deadlines that are too short often result in:
  • Hurried research.
  • Documents that lack detail.
  • Mistakes that could have been avoided if ample time for the project had been provided.

If possible, include the contractors in the setting of the project milestones and deadlines. Professional documentation experts will often have a better understanding of the amount of work and time required for particular deliverables. This can result in shorter rather than longer deadlines.

Ensure that you provide constant feedback to the contractors concerning your satisfaction with their work. A summary meeting upon project completion is an excellent idea, especially if you think you will want to work with those contractors again.

Summary
Many smaller biotech and healthcare companies are challenged daily to manage their internal resources to fulfill their ever-changing needs. Outsourcing scientific and medical writing projects is one way to alleviate that stress on available resources. Expert scientific and medical writers will provide guidance in crafting documents that communicate the desired information for the intended audience, and complete the writing project on time and on budget. Indeed, the sponsor may find that a valuable new partner has been added to their team, providing a significant resource for future scientific and medical writing endeavors.

References
Lele, C and Rothman 2011. L.Global Forum 3(2). Available: www.sciformix.com/wp-content/uploads/BP2-Sciformix3.pdf (Accessed March 10. 2014).