Aravinda Bio Solutions
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Aravinda Biosolutions is a full-service Contract Clinical Research Organization. It caters to pre-clinical and clinical development programs of the pharmaceutical, biotechnology and medical device industries at a global level.
It is mandated to provide quality services in the areas of project management, clinical operations, biometrics, regulatory affairs, document management, quality assurance, training, medical writing, pharmacovigilance, medical consultancy and laboratory services.
Aravinda Biosolutions offers facilities and consultation for drug storage, inventory, temperature-controlled transport and early custom clearances for clinical trial supplies such as drugs, vaccines, other biologicals, devices, laboratory kits, equipment, and trial documents. These services are also compatible with the use of centralized randomization and blinding techniques.
The supplies customs-cleared and stored under customer-specified conditions with complete access control and disaster management and distribution is traced up to the delivery to site in accordance with Aravinda Biosolutions SOPs. Tertiary storage areas designated for drugs and biologicals are maintained at room temperature, refrigerated and freezer temperatures with daily temperature monitoring and back-up generators. Aravinda Biosolutions also arranges for return and/or destruction of expired, unused and damaged trial supplies under customer-specified conditions.
Aravinda Biosolutions offers secure off-site document and electronic data archival facilities and consultation for investigational sites. These archival facilities operate in accordance with SOPs that ensure complete access control and disaster management for business continuity. A Records Management Liaison Officer is appointed for each archival project and is responsible for understanding the customer expectations, managing the transfer of documents to the facility using the agreed mode of transfer and ensuring timely and controlled retrieval. Each batch of project documents is bar-coded and maintained under stringent physical and logical security, temperature/ humidity level maintenance and environmental hazard control until such time as they are returned to the customer/ destroyed as per Aravinda Biosolutions' SOPs. The documents that can be archived include CAT scans/MRIs, X-rays, ECGs and Case Report Forms.
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