Virtual consultants, also known as teleconsultants, have transformed the traditional view of the consulting field. One is no longer stuck playing host to a mixed team of experienced experts and junior consultants.
Today, you can pick a senior consultant to deliver his or her individual, specialized expertise over the phone or via the Internet. This can include anything from online seminars to phone or email consultations, or even a conference call with an independent advisor to double-check information provided by an onsite consulting team from a different company.
Teleconsulting services lower costs, improve productivity, and reduce risk. So what are the compliance related services available? Should you use a virtual consultant? And what does the FDA want to see when it comes to the qualification of a virtual consultant as a supplier?
Telecommuting to Teleconsulting
Many teleconsultants got their start when their previous employers went out of business or reduced staffing. Drawing upon the concept of telecommuting that began back in the mid-1970s, these new freelancers went into business for themselves, offering their expertise over the phone and via fax. Common activities for which they were hired included proofreading and copyediting corporate documents like reports and presentations, as well as writing marketing copy or company newsletters.
The advent of the internet, email, networks, and video-conferencing allowed the burgeoning teleconsulting market of the 1980s and 1990s to blossom. Today, you can find virtual consultants in nearly every profession – accounting, legal services, and even medicine (witness the growing field of telemedicine). A quick internet search on the terms “teleconsulting” or “teleconsultant” will generate over 32,000 service offerings from which to choose.
While most of us in compliance might still think of teleconsultants as freelance contractors to hire when lots of standard operating procedures (SOPs) beckon, the copywriting and editing expertise of a teleconsultant may be his or her most basic skills. When it comes to quality systems and regulatory compliance, you may be surprised at all the help now available at the click of an email.
Using the Internet, telephone, and even videoconferencing, virtual consultants can help deliver value far beyond SOP drafts. For just compliance, examples of virtual consultant services you can find today include:
- Online seminars on specific topics, regulations, or best practices
- Niche expertise advice via phone or email
- Document reviews of draft regulatory submissions
- Help with responses to FDA or other third party inspectional observations
- Compilation of regulatory or quality systems intelligence reports and updates
- Research on specific questions (such as TK sample retention requirements)
- Overflow help for regular events (for instance, helping you prepare for your annual quality systems management review or helping you analyze CAPA trends)
- Independent reviews of important presentations or articles to ensure compliance accuracy
- Advice on country-specific regulations and expectations for the region in which the virtual consultancy is based
Note that all the items on this list are short-term assignments. The more defined and limited the scope, the greater your chance of success with a virtual consultant.
This is the strength of virtual consultants: their laser focus on specific niches of expertise. When firms approach me about computer validation, I let them know that while I can help them devise or assess their validation strategy, review validation packages, provide advice on maintaining validated systems to cut costs and risk, or even run a workshop for them on validation best practices, it would not be a good use of anyone’s time or money to hire me to actually perform the validation. After all these years, my expertise is no longer there – it’s on those small niches of validation strategies and practical long-term maintenance.
Before you bring in a virtual consultant, the first thing to do is sit down with your team and brainstorm options where you can get the best value for your time and money. Is your team up to date on all the new process validation expectations from the FDA? Perhaps you can hire a teleconsultant to provide a three-page summary of expectations gleaned from the new validation draft, recent ICH or GHTF guidelines, and FDA warning letters over the past 12 months.
Are you about to embark on a regulatory submission? Perhaps you can hire a virtual consultant to identify the ten most common adverse events reported with a similar or competing drug or device; or have the virtual consultant review a draft of your Risk Evaluation and Mitigation Strategy (REMS).
Do you need to conduct computer validations? Rather than running out and hiring validation consultants who may have a conflict of interest when it comes to advising you on what needs to be validated and to what extent, perhaps you can hire a virtual consultant to review your plans and provide suggestions and priorities; or have him/her conduct a warning letter search of recent computer validation citations to ensure your plans addresses these issues and limits your risk.
The primary benefit of any virtual consulting program is its lower cost – you don’t need to pay for travel and you don’t risk the consultant looking for a permanent gig. If you do not see a defined time limit in the scope of any proposal, along with clear checkpoints or milestones along the way, beware. You want to pay for – and get – a specific, scope-delimited deliverable.
Short engagements – and no consultants pushing for a longer one – translate to a relatively quick turnaround for any project, thus improving your team’s productivity. In my experience, virtual consultants tend to be upfront about their ability to meet your needs. Unlike typical consulting firms with higher overhead from offices, marketing and sales personnel, administrative staff, and so on, the virtual consultant is most often dependent on word of mouth and reputation; quality of work (as opposed to length of contract) cannot afford to suffer.
Another benefit of teleconsultants can come from using their know-how and expertise to stay on top of current and emerging best practices. A virtual consultant whose knowledge is only based on his or her career at the FDA fifteen years ago is going to find business rapidly dwindling. Most teleconsultants that I know aggressively stay on top of new FDA expectations and industry best practices associated with their field – including awareness of trends and new techniques in non-FDA industries.
Career development and management best practices, such as the Regulatory Affairs Professional Society’s Regulatory Affairs Professional Development Framework (2007), suggest regulatory affairs personnel allocate as much as 30% of their time to strategy activities like gathering regulatory intelligence, and then synthesizing and translating it into business initiatives. Here too, the virtual consultant can help you by doing a great deal of information gathering and synthesizing for you, leaving you to focus on translating the specifics appropriate to your organization.
Risks and Obstacles
There are some obstacles you should be aware of before you conduct your internet search of compliance teleconsultants. For one, because of their niche expertise, teleconsultants will often set an hourly rate or fixed fee that may make it difficult to comparison shop.
For instance, I can name the individuals in North America that provide expert advice on FDA compliant pharmaceutical, biologics, and medical device records and document controls and retention requirements; there are fewer than a handful of us. And chances are, by the time you are looking to fill that niche, you have a need that largely outweighs the minor amounts of money you might be able to save by trying to comparison shop.
The second obstacle to overcome when looking for and employing virtual consultants is internal to your company: you may not be set up to handle this kind of small, one-off niche expert. I’ve seen six page vendor setup forms wherein the amount of effort required to complete the form, combined with the contract the firm wanted, would have taken more time to put together than to answer the specific good laboratory practice regulation questions they had.
Your firm may also have an internal process in place wherein any contract services must be reviewed by legal prior to engagement. Whether your company wishes to spend $415 in legal fees for a $250 contract may be an unwelcome business decision you force to the forefront by looking to hire a niche-expert to help with one specific item.
Most virtual consultants also have a blanket limit of liability / warranty statement such as:You agree that Consultant XYZ’s answers will be limited to a discussion of the pertinent information you provide. You agree that Consultant XYZ’s answers will not be the sole basis upon which your make decisions, nor will the answers provided be construed as legal advice or a legal opinion on specific facts and circumstances. You agree that Consultant XYZ will assume no liability for actions taken or not taken as a result of our phone / email consultation. You also agree that if the information Consultant XYZ provides is incorrect, your recourse will be limited to a full refund of the teleconsulting fee paid within 30 days following written notification as to the incorrect information.
Review this type of one paragraph warranty / liability statement with your legal counsel. The key from your standpoint is to ensure three things:
- That any liability statement can be a template you can use moving forward with other virtual consultants;
- That the liability statement provides you a reasonable way to get your money back; and
- That the condition(s) under which you can get your money returned are clear and explicit (in the above case, it’s 30 days after you inform the virtual consultant in writing the information he/she provided was wrong)
Be upfront with your legal counsel about how much this virtual consulting service is going to cost; in-house counsels I’ve talked with do not want to be involved for anything less than $5,000 USD. It is extremely unlikely you are going to go to court for that amount or less (the most recent statistics I saw showed that it cost $18,000 in legal fees just to initiate a civil lawsuit in the US – much less conduct and hopefully win it). Point out that you want a basic paragraph warranty / liability statement that you can use as a template – or refer to from a comparative standpoint if the teleconsultant has one already in his or her virtual consulting proposal.
Depending on the nature of the work involved (for instance, reviewing your draft new drug application), you may want to push for a non-disclosure or confidentiality agreement. I strongly recommend you push your default non-disclosure agreement when at all possible; you are the one providing confidential information to the consultant – not the other way around – so his/her refusal to sign your default confidentiality agreement should be a red flag.
Finally, make sure to check with your accounting department to ensure your company can handle how virtual consultants bill. Under a typical “work for hire” arrangement, the work is completed first, then the invoice is sent, and finally, you pay. When it comes to virtual or teleconsultants, however, the more common expectation is for some amount of money be paid up front. This is due to the risk the remote expert runs in agreeing to help you. Virtual consultants provide information-centric, experience-based service (for instance, researching out and answering a specific question); once the question is answered, the work is done. At that point, he or she has no leverage in your relationship. You are free to walk away without paying your bill.
Given that you may be paying as little as $100 – $200 (USD), and few companies are going to go to court over $200, the teleconsultant runs a real risk of being left “high and dry” for his/her services (pick up any consulting business literature on writing proposals and the number one piece of advice is to always get some payment up front). To minimize the risk of a client walking away after getting the information desired, a virtual consultant will expect some degree of upfront payment; typically, anywhere from 25 – 50% of the fee. And if you choose to find your teleconsultant through independent expert matching services, you will be expected to put the full fee into an escrow account prior to the engagement.
Steps to Qualify
The FDA requires that companies qualify their suppliers – including consultants (for device firms, this expectation is enshrined in 21 CFR 820.50, for drug and biologics, the rule is 21 CFR 211.34). As we will see in the below steps, the key to proving that you qualified the virtual consultant appropriately is this phrase from the regulations: “Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.”
So how do you qualify a virtual consultant? And given that you may be paying a very small price indeed for that consultant’s advice, how can you qualify him/her for less than the advice will cost?
The steps I recommend in my article Choosing and Getting the Results You Expect from Consultants are best practices for selecting and qualifying any consultant, but they may be too time-consuming for someone you plan to only work with for an hour or two. In that case, we can look back two thousand years to Aristotle, who wrote “There are three things that inspire confidence in [one’s] character: common sense; a polite, well-disposed attitude; and a sound moral reputation.”
Consider a simple seven step process you should be able to complete in less than 45 minutes:
- Conduct a search on the FDA Debarment List website; as a best practice, consider also conducting the same search on the U.S. Department of Commerce’s Bureau of Industry and Security Denied Persons List
- Review their reputation. This can be done through recommendations from colleagues, reviewing the list of their publications (have they published anything?), and – if you are using a freelance matchmaking website – do they have any ratings or testimonials from previous customers?
- Review their biographical background and look for the regulations for which they are experts.
- Do they post their industry association memberships and are those in alignment with your memberships? If you are a medical diagnostics firm, does the consultant you have in mind belong to the Association of Medical Diagnostics Manufacturers (AMDM)? Keep in mind that associations whose dues are over $450 a year for individual membersare not likely to have many – if any – virtual consultants as members.
- Look at the form or teleconsulting webpage the virtual consultant has established for remote consulting. Does the document provide you some level of warranty and the consultant some level of limited liability? Does this include the ability to obtain your money back? Is some level of payment required upfront?
- Finally, assess their payment options. Is it by invoice and check? Will they take purchase orders? If they suggest payment through a respected online payment processor (such as PayPal), is the virtual consultant a “verified business”?
If you are going to pay the virtual consultant electronically, making sure he/she is operating as a “verified business” is a critical qualification step. Verified business status allows for dispute resolutions that do not risk your money (e.g., your credit card or direct bank payment is not charged until the dispute is settled). A virtual consultant who is a verified business has provided the online payment processor (i.e., PayPal, etc.) a direct link to his/her bank account. Because of this link, the payment processor verifies that the virtual consultant is a real business, has a valid, sustainable, bank account, has conducted business beforehand, and is – at least financially – trustworthy.
Based upon your quality systems requirements, consider retaining at least the following records as part of your “supplier qualification” file for the virtual consultant:
- Testimonials, ratings, publications, etc. establishing his/her industry recognized expertise
- Biographical information, business address, and specific expertise relevant to you
- The unsigned proposal and/or form used that includes any warranty or limited liability information
Retain these records to help you defend your selection to any inspector who enquires as to how you came about working with the virtual consultant.
Teleconsulting continues to grow as executives look for ways to get the help they need at a more affordable price. Hiring a virtual consultant to be an “on call, as needed” expert may be just the right level of expertise called for.
Are you ready?Adapted from an article published in SmarterCompliance 3(7), July 2009