Waltham, Mass.-based contract research organization (CRO) Parexel has grown its early phase operations with an expansion of three clinical pharmacology units (CPUs), located in Baltimore, London and Berlin.
The expansion brings the company’s total worldwide phase I bed capacity to 550, one of the largest in the industry, the company stated. Parexel also has CPUs in San Diego and Los Angeles, and two facilities in South Africa. Each of its phase I facilities uses its clinical trial management and electronic data capture (EDC) technology, ClinBase. The company’s early phase services include bioanalytical services, data management, biostatistics, medical writing, pharmacokinetic services and consulting.
Parexel expanded its London facility to 64 beds. With a strong focus on respiratory disease and cardiac safety, the unit has a separate respiratory laboratory, and can provide cardiac telemetry and electrocardiogram (ECG) monitoring. The unit has been operational for 15 years.
The company’s Baltimore facility, which specializes in immunology, pulmonary and oncology studies, will be expanded to 90 beds. The facility boasts the ability to conduct state-of-the-art imaging and radiochemistry testing—an area of increasing demand in clinical trials. It uses positron emission tomography (PET) equipment. The unit opened in 2001.
The CRO’s two CPUs in Berlin now have a 160-bed capacity combined. The phase I units specialize in advanced sleep research using their own dedicated sleep laboratories. Both units conduct studies for cardiovascular, central nervous system, respiratory, dermatology, metabolism and endocrine and infectious disease.
The company can conduct trials in India through Synchron Research Services, a Bangalore-based CRO it controls though a majority-owned stake. Parexel also runs phase I services in India through a partially owned venture with Synchron’s Ahmedabad-based facility, which has about 86 beds. Last month, Parexel increased its ownership stake in that venture from 19.5% to 31% at a cost of $5 million.
“There has been significant demand from a range of clients, including small and emerging bio/pharmaceutical companies, medical device companies, and large pharmaceutical companies, requesting clinical research services in India, one of the high growth emerging economies. Recent reforms in the regulatory system in India have increased approval rates of studies. Additionally, India will become an even more attractive location for clinical research as other systems and laws are implemented, such as the patent system and data exclusivity laws,” said Josef von Rickenbach, Parexel’s chief executive officer.
At the same time, Parexel sold its France-based bioanalytical and biomarker testing laboratory facility—owned since 1999—to a subsidiary of Synchron for approximately $6.7 million. The Good Laboratory Practice (GLP) Class A certified unit will now be called Synexel Research International and will stay within Synchron’s operational network. All of the lab’s staff will remain.
In April 2007, Synchron acquired Innovance, a 64-bed, 18,000-square-foot research center and 14-bed phase I facility. The company also started Thailand’s first early stage CRO, Bio-Innova, in Bangkok.
“We are looking for more operations in other countries soon to increase our footprint in Asia,” stated Shivprakash Rathnam, Synchron’s founder and chief executive officer.
According to the Business Standard of India, Synchron is expanding its services to Vietnam with a new $2 million research facility. The company is planning to go public in the next two years.