Manipal Acunova Limited

	Bioavailability and Bioequivalence Services
	Clinical Data Management
	Central Reference Lab
	Clinical Trials and Research
	Site Management Services

BIO IMAGING & CARDIAC SAFETY

IMPORTANCE OF CORE IMAGING

Imaging as an end point in clinical trials has increased manifold in recent years. Regulators like FDA have put on fast track review, drugs developed with imaging as an end point. Through imaging there is now a new level of understanding available on how drug development candidates directly affect specific biological processes within the human body, providing early insights in the drug development process. Increasing use of imaging is expected to make pharmaceutical development more efficient and productive. Use of imaging requires special competency of blind reads, measurements, reconstruction and QA.

AcuNova has access to two global radiology remote reading units of the Manipal Group - one at Bangalore, managed by the Manipal Clinical team. This unit delivers 3D reconstruction to reputed hospitals in Massachusetts State. It is equipped to do clinical trials reading. AcuNova has developed clinical trials image reading capabilities- 4 Ways Healthcare Ltd, at London. 4 Ways Healthcare delivers remote radiology reading services to clients including NHS in the UK.

CARDIAC SAFETY

Regulatory agencies worldwide continue to emphasize the inclusion of electrocardiograms (ECGs) in clinical trials to interpret cardiac patient safety before drugs are cleared for marketing. FDA & global regulatory authorities require many new drugs to undergo intensive TQT studies conducted by a centralized laboratory using validated, digital analysis of ECG waveforms and manual QT interval determinations by a designated skilled reader.

For fulfilling and complying with these requirements, Manipal AcuNova has entered into a joint marketing agreement with eResearch Technology, Inc., where eResearch Technology provides ECG interpretation services to clients, while AcuNova conducts in its pharmacological unit focused TQT studies. These studies are typically for medical diagnostic companies with therapeutic specialties in oncology, cardiovascular and CNS.

Imaging and Cardiac Safety services with India advantage is now being welcomed by discerning global clients. In this space, Manipal AcuNova has established advantages in quality data, in-depth expertise through collaborations and our talent pool as well as detailed planning on projects and data management.

For more details please email : client@acunovalife.com