Key Questions to Ask When Outsourcing Pre-clinical Development Services

By Peter Pekos, President & CEO, Dalton Chemicals Inc.

More and more pharmaceutical, biotech and academic institutions are turning to clinical research organizations (CROs) to assist them with drug discovery and development services. A lack of specialized expertise, tight time frames and the need for optimal resource utilization is leading more research departments to seek out outsourcing solutions to everything from drug discovery to manufacturing.

In doing so, it is becoming increasingly important to review CROs comprehensively to ensure the company chosen will become a true strategic partner as a candidate moves through the drug development process, rather than simply a project-based supplier.

While large pharmaceutical companies will conduct formal audits, smaller biotech and academic institutions should also conduct comprehensive reviews as part of their due diligence. That research should include the following questions being answered to their satisfaction:

How many of the scientists on staff have Ph.D.s? Do they have a broad range of chemical and technical expertise, such as synthetic route and process development?  Or is their expertise limited to one area?  What is the ratio of scientific to commercial and administrative staff within the company?

Make a practice of reviewing your CRO’s training and retention programs to ensure your scientific knowledge bank grows with your business relationship.

How will your project be managed? Is a Ph.D. overseeing a cross-functional research team? What is the ratio of laboratory technicians to chemists to project managers on your study? At Dalton, we ensure that one full-time equivalent assigned to our customers’ business is comprised of one full-time chemist in addition to support from a

laboratory technician and a senior project manager.

What is the company’s approach to communications? Open and constant communication between a CRO and their client is imperative throughout the duration of the study to ensure that decision points around issues that arise are acted upon swiftly. If your research priorities shift due to a patent filing or other deadline, can this CRO shift its personnel in response to your needs?

managers, should also be reviewed for breadth of expertise and the organization’s quality parameters should meet or exceed your own institution’s internal benchmarks. Importantly, standard operating procedures should be apparent in every aspect of work the CRO undertakes, from their service offerings to their communications with their customers.

First and foremost, does this facility meet or exceed existing regulatory requirements and safety standards? Are the manufacturing suites cGMP compliant and are analytical laboratories suitable for your project? How secure is the facility? Who has access to the labs? Is your proprietary information safe from mischief and environmental problems? Will the information technology infrastructure sustain the integrity of your data or put it in jeopardy? What steps has the CRO taken to ensure the privacy of your data? Tour the facility and ask questions of all levels of staff  as you do.

A CRO’s breadth of services provides clues to its ability to meet all of your needs, adapt to your changing requirements and become a long-term partner. Does the organization have strong in-house analytical capabilities? Are they capable of scale-up and process development? Do they have sterile filling capabilities? Review your current and future needs and ask about their services accordingly. The bottom line: can they support your research needs as drug candidates make the leap from lead candidate to commercialization?

The true litmus test of any research partner is its track record. At the base, ask if the company has been inspected and certified by the Therapeutics Product Program of Health Canada. Are they compliant to Food & Drug Administration regulations?

When these questions are answered to your satisfaction, ask for client references and case studies that demonstrate a strong scientific bias in the staffing of the organization; hands-on, communicative management that offer solutions throughout the project, not just problems; a world-class facility; a wide breadth of service offering from the laboratory to analytical projects; and the ability to deliver on time and on budget.

Dalton Chemical Laboratories Tel: 416-661-2102. 

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