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Right on Time

EPC: What is PSI’s background and how did you start in the clinical trials area?

Olga Alfonsova: PSI started in 1995, primarily in the patient enrolment area in clinical trials. It was founded by a team of talented people who wanted to make an impact. All of them, by the way, are still on board and engaged in PSI’s day-to-day management. Historically, we were brought in to perform rescue contract research organisation (CRO) services and help with difficult-to-enrol studies. This taught us to focus on what we are good at and concentrate our efforts in the area of on-time clinical trial delivery, which is perhaps the biggest challenge for any CRO.

How have you been able to deliver clinical trial projects on time?

Project delivery is a rampant problem in our industry with – according to different sources – more than 90 per cent of projects running behind schedule. We never liked these statistics. Contrary to the ‘normal’ industry performance, 95 per cent of PSI studies are on or ahead of schedule. This sustainable performance is a result of dedicated focus on two things: proper feasibility and ‘go-the-extra-mile’ project management.

What changes have you seen in the past 12 months?

Pharma and biotech sponsors have become much more careful and pragmatic about how they spend their R&D money. They have become more selective and tend to look for solutions that offer patient enrolment guarantees. This used to be more typical of smaller biotech sponsors, but now mid-size and larger pharma are gradually catching up with the trend. Perhaps, as an industry, we now have a better chance to finally revert the late delivery statistics.

How are you tackling feasibility of clinical trials?

Every project receives a thorough assessment along the lines of medical, clinical, regulatory, logistical and laboratory feasibility. Dedicated experts in each of the above fields join forces to come up with a well-balanced assessment that addresses a broad range of eventualities, characteristic of contemporary clinical trials.

What geographic areas are you seeing the most growth in?

Many clinical trials are coming to Asia and the trend is likely to continue. We also see a growing number of requests for South Korea, India (despite the current regulatory turmoil) and South Africa. The world is really flat now, and CROs need to be ready to face the twofold challenge: be global and be on time.

What do you think the industry needs to focus on at the moment?

The industry needs to learn the true sense of time and delivery attained through CRO partnerships. In our industry, delays tend to be rewarded. It is almost more profitable for a CRO to be late delivering a study, pointing fingers at competition and complex regulatory environments. By and large, CROs have lost the sense of project ownership. The true meaning of service needs to be brought back into clinical research, which, in itself, will be a sign of a maturing industry.

What are your goals for the coming year?

Our goal is to excel at what PSI does best. Do better feasibility assessments, be on time delivering clinical trials, grow wisely, keep training, invest in talent, and nurture loyalty and accountability.

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Olga Alfonsova is Head of Business Development at PSI CRO AG (www.psi-cro.com), a global, full-service CRO specialising in on-time project delivery. Over the last 19 years PSI has grown to more than 1,400 staff in over 50 countries, while maintaining exceptionally high repeat and referral business rates. Olga joined PSI in 1994 and is currently based in Zug, Switzerland, where the company is headquartered.
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