Dec 21, 2005
Spacelabs Medical Data Commences Multinational Clinical Trials With Major Pharma Company
Spacelabs Medical Data Commences Multinational Clinical Trials With Major Pharma Company
Spacelabs Medical Data Commences Multinational Clinical Trials With Major Pharma Company
Spacelabs Medical Data, a division of Spacelabs Healthcare, Inc.
announced today that it is providing real-time, on-demand ambulatory
blood pressure (ABP) monitoring for two
large clinical studies being conducted by a major international
pharmaceutical company.
The clinical studies involve over 1,000 patients at more than 125 investigational sites in 11 countries. Patients are wearing the Spacelabs 90207 ABP monitor during the trial which automatically captures the ABP data. Measurements are then being uploaded into a proprietary, intuitive new PDA interface, which stores the data and performs calculations to determine technical and protocol-specific success criteria. The PDA also allows the electronic transfer of ABP data to Spacelabs Medical Data, where it is compiled for electronic submission to the sponsoring pharmaceutical company.
The benefits of using Spacelab Medical Datas PDA systems to patients, sponsoring pharmaceutical companies and investigative sites are multiple. These include a new level of convenience and time efficiency which has the potential of reducing the overall costs of conducting a clinical trial. In addition, the PDA equips investigators with on-the-spot determination of the evaluability of ABP data which is a convenient safeguard against the enrollment of ineligible subjects.
There is also instant notification if a repeat procedure is necessary to avoid data loss or to gather additional safety data.
Director of Operations of Spacelabs Medical Data, Tania Issa, stated, "Traditionally, monitoring a patients ABP during a clinical trial was a time-consuming and inefficient process. Now, Spacelabs PDA interface allows real-time monitoring and data processing in a fraction of the time. We believe the resulting benefits to patients, clinical sites and pharmaceutical companies are significant."
About Spacelabs Medical Data
Spacelabs Medical Data (www.spacelabsmedicaldata.com) is a leading global provider of centralized ECG and ABPM research services for pharmaceutical companies, biotechnology firms, academia, CROs and device manufacturers. Founded in 1985, Spacelabs Medical Data offers expertise across the full spectrum of ECG services, including 12-lead ECG, Holter monitoring (12-lead and 3-channel) and ABPM for phase I through IV clinical trials. Spacelabs Medical Data is a division of Spacelabs Healthcare, Inc.
About Spacelabs Healthcare, Inc.
Spacelabs Healthcare, Inc. (www.spacelabshealthcare.com) is an international developer, manufacturer and distributor of medical equipment and services including patient monitoring solutions, anesthesia delivery and ventilation systems, pulse oximeters and sensors and bone densitometers selling to hospitals, clinics and physicians offices. Additionally, the company provides ECG and ABPM Core lab services for the clinical research industry.
The company has established brand names in both medical devices and medical services such as Spacelabs, Blease and Dolphin. The company employs approximately 1,050 personnel in its 14 offices in UK, Canada, France, Germany, Finland, Singapore and the United States. The company conducts its manufacturing and R&D in India, the UK and the United States.
Spacelabs Healthcare is listed on the London Stock Exchange (LSE: SLAB) and is a subsidiary of OSI Systems Inc., a US-based, Nasdaq-listed company.
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include information regarding our expectations, goals or intentions about the future, including, but not limited to, statement regarding future success of the PDA interface or the Spacelabs 90207 ABPM or Spacelabs Medical Data . The actual results may differ materially from those described in or implied by any forward-looking statement. All forward-looking statements speak only as of the date made, and we undertake no obligation to update these forward-looking statements.
CONTACT
Tania Issa, Director of Operations
Spacelabs Medical Data
+1 425-657-7200, ext 5402
email: SMDinfo@slmd.com
The clinical studies involve over 1,000 patients at more than 125 investigational sites in 11 countries. Patients are wearing the Spacelabs 90207 ABP monitor during the trial which automatically captures the ABP data. Measurements are then being uploaded into a proprietary, intuitive new PDA interface, which stores the data and performs calculations to determine technical and protocol-specific success criteria. The PDA also allows the electronic transfer of ABP data to Spacelabs Medical Data, where it is compiled for electronic submission to the sponsoring pharmaceutical company.
The benefits of using Spacelab Medical Datas PDA systems to patients, sponsoring pharmaceutical companies and investigative sites are multiple. These include a new level of convenience and time efficiency which has the potential of reducing the overall costs of conducting a clinical trial. In addition, the PDA equips investigators with on-the-spot determination of the evaluability of ABP data which is a convenient safeguard against the enrollment of ineligible subjects.
There is also instant notification if a repeat procedure is necessary to avoid data loss or to gather additional safety data.
Director of Operations of Spacelabs Medical Data, Tania Issa, stated, "Traditionally, monitoring a patients ABP during a clinical trial was a time-consuming and inefficient process. Now, Spacelabs PDA interface allows real-time monitoring and data processing in a fraction of the time. We believe the resulting benefits to patients, clinical sites and pharmaceutical companies are significant."
About Spacelabs Medical Data
Spacelabs Medical Data (www.spacelabsmedicaldata.com) is a leading global provider of centralized ECG and ABPM research services for pharmaceutical companies, biotechnology firms, academia, CROs and device manufacturers. Founded in 1985, Spacelabs Medical Data offers expertise across the full spectrum of ECG services, including 12-lead ECG, Holter monitoring (12-lead and 3-channel) and ABPM for phase I through IV clinical trials. Spacelabs Medical Data is a division of Spacelabs Healthcare, Inc.
About Spacelabs Healthcare, Inc.
Spacelabs Healthcare, Inc. (www.spacelabshealthcare.com) is an international developer, manufacturer and distributor of medical equipment and services including patient monitoring solutions, anesthesia delivery and ventilation systems, pulse oximeters and sensors and bone densitometers selling to hospitals, clinics and physicians offices. Additionally, the company provides ECG and ABPM Core lab services for the clinical research industry.
The company has established brand names in both medical devices and medical services such as Spacelabs, Blease and Dolphin. The company employs approximately 1,050 personnel in its 14 offices in UK, Canada, France, Germany, Finland, Singapore and the United States. The company conducts its manufacturing and R&D in India, the UK and the United States.
Spacelabs Healthcare is listed on the London Stock Exchange (LSE: SLAB) and is a subsidiary of OSI Systems Inc., a US-based, Nasdaq-listed company.
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include information regarding our expectations, goals or intentions about the future, including, but not limited to, statement regarding future success of the PDA interface or the Spacelabs 90207 ABPM or Spacelabs Medical Data . The actual results may differ materially from those described in or implied by any forward-looking statement. All forward-looking statements speak only as of the date made, and we undertake no obligation to update these forward-looking statements.
CONTACT
Tania Issa, Director of Operations
Spacelabs Medical Data
+1 425-657-7200, ext 5402
email: SMDinfo@slmd.com