CRO Services for Drug-Device and Drug Delivery Combination Product Manufacturers by Alquest

Alquest Combination Products Profile

Clinical • Regulatory • Compliance

Since 1994 Alquest – The Specialized CRO™ – has supported the development and approval of more than 15 combination products through its clinical, regulatory and compliance services. In addition to being the CRO of choice to more than 300 medical device companies, Alquest ranks among the top research services firms in North America for its depth and breadth of experience in combination products. Consider our experience:

Fibrin coated stent (device-biologic): Regulatory/clinical strategy, IDE submission, clinical initiation
Bone morphogenetic protein (biologic-device) combination products for spinal and dental indications: Regulatory/clinical strategy, PMA submissions, clinical audits, monitoring, data analysis, clinical reports
Transdermal iontophoretic drug-delivery patch for post-surgical pain (drug-device): Submission strategy, preparation of the device-portion of the NDA, regulatory support for and participation in pre-approval inspection
Pulmonary vein isolation drug delivery system to treat atrial fibrillation (drug-device): Regulatory strategy and pre-IDE guidance
Needleless injection system to treat diabetes-related indication (drug-device): Regulatory strategy, 510(k) review, compliance support
Blood/IVD combination product for blood supply analysis (biologic-device): Clinical study management, monitoring, data analysis, clinical support preparation for BLA
Drug eluting catheter (drug-device): Regulatory strategy, 510(k) submission review
Drug eluting pacing lead (drug-device): Regulatory strategy and PMA supplement preparation and review
Cell processing equipment (biologic-device): Regulatory strategy, pre-IDE meeting conduct, manufacturing support, 510(k) submission support
Implantable morphine pump for pain management (drug-device): PMA supplements, clinical reports
Pheresis system for cancer indication (biologic-device): Pre-IDE, animal support, regulatory-clinical project planning
Ultrasound-guided system to deliver thrombolytic biologic (biologic-device): IND submission, monitoring, clinical study support
Injectable collagen/polymer-based controlled delivery system (biologic-device): Regulatory strategy, pre-IDE meeting, submission preparation
Multiple cellular therapies aided by electric stimulation (device-biologics): Regulatory strategies
Photoporphyrin-facilitated cellular ablation: Prepared Request for Designation
Implantable pump for antiarrhythmic drug delivery (drug-device): Regulatory strategy, clinical study protocol

Conferences:

November 10-11- San Diego, CA
Effective Clinical Trial Strategies for Combination Products
Drug & Device Combination Forum
Alquest staff to present

Presentations:
Alquest staff members are active in presenting their expertise on combination products to industry:

Effective Clincal Trial Strategies for Combination Products
Drug & Device Combination Forum
San Diego, CA – November 10-11, 2008

Drug Device Combination Products: A Regulatory Perspective
2008 RAPS Annual Conference & Exhibition
Boston, MA – September 16-17, 2008

What Applies: GMP and QSR
Pharma MedDevice
INTERPHEX
New York, NY - March 26, 2008

Global Clinical Trials for Combination Products
Informa Life Sciences: Drug-Device Combination Products Conference
Brussels, Belgium, December 4-5, 2007

Combination Products: Opportunities & Challenges
RAPS San Francisco Bay Area Chapter and ASQ Biomedical Discussion Group
San Francisco, April 27, 2007

The Overlap of Good Manufacturing Practices (GMP) and Quality System Regulation
Pharma MedDevice 2007
New York, April 25, 2007

Streamlining Clinical Studies for Combination Products
Drug Delivery Partnerships Conference Group
Phoenix, January 27, 2006

Developing Combination Products
Barnett International Conference Group
San Diego, March 7-8, 2005

Current Status of Combination Product Regulation
Minnesota Quality Conference/Biomedical Focus
Minneapolis, April 14, 2003

Combination Products: Utilizing Industry Best Practices from Proven Strategies in the Field
Barnett International Conference Group
Philadelphia, PA, November 18-19, 2002

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