Medifacts sells CRO unit after bankruptcy reshuffle

Medifacts International has sold its contract research organisation (CRO) unit after a reorganisation sparked by the firm's filing for Chapter 11 bankruptcy protection in February.

The sale of the division, which provides Phase I-IV clinical trial services, will leave the troubled firm with only its cardiac safety services unit, which supports the acquisition of data to determine the safety and/or efficacy of drugs or devices in clinical trials, for which it now plans to implement "a financial restructuring."

Company CFO Lynn Michl told Outsourcing-Pharma.com in an earlier interview that he was unable to comment on the reasons for the sale or any other details of the bankruptcy filing.

Meanwhile, Bruce Garrett, the medical director of the Clinical Research Services division while it was owned by Medifacts, has bought the unit in an undisclosed deal and told Outsourcing-Pharma.com that he is "full of a whole bunch of new ideas on how to change it for the better."

"The business is currently financially ok, but we need to improve it," he said.

Garrett said he will be placing a strong emphasis on quality systems and performance and implementing new techniques and standard operating procedures (SOPs).

In addition, he plans to run the global arms of the business in a more integrated fashion, particularly in the areas of data management and safety reporting, to avoid workload duplication and unnecessary spending.

Garrett also added that it will be "business as usual" in the division, which has kept its existing employees and clients and will retains its focus on cardiovascular and metabolic diseases, while operating under the new name of Global Research Services.

Moving forward, the company, which currently has a presence in the US, Germany, Poland and China, is earmarked for expansion within Poland and into the new territories of Czech Republic and Hungary within the next year.

For cardiovascular research these regions have lots of experienced investigators and a lot of patients with cardiovascular disease who are very keen to enter trials and receive potential new treatments.

In addition, the hospital systems in these countries are very concentrated and there is a captive pool of patients that are easy to identify, said Garrett.

"As a result, recruitment is around 25 per cent faster than in Western Europe ," he said.

"This time saving is our main driver in going to these regions to run trials - if we can save 30 days on a trial for a client, this can translate into anywhere from $7.5m (€5.6m) to $30m in extra sales revenue for the firm."

On the subject of cost savings, Garrett added that many Central/Eastern European countries no longer offer significant cost savings over their western counterparts.

"These countries used to be much cheaper but in the last year we have noticed that prices have gone up so that they are only 10-15 per cent cheaper than the west," said Garrett.

"These countries know how much is charged for clinical services in the west and have raised their prices and salaries accordingly.

In addition, hotel and restaurant prices have also risen considerably and value added tax (VAT) is high - 22 per cent in Poland for example."

Meanwhile, the firm said that China, where it has a biometric data processing centre in Shanghai, is also an area of growth focus.

"Our goal is to expand our early-stage consulting team so that we can provide select clients with comprehensive product development services."