Office (925) 480-7497
Mobile (925) 413-7297
Email: aretzios@ADRclinresearch.com

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Services

Product Portfolio Review

We can help you understand the strength and weakness of your portfolio at any stage of your development, the potential risks as well as the opportunities and the possible avenues of development to help you concentrate resources in the appropriate area.  This effort incorporates Target Product Profiles, existing product labels, marketing research for the potential competitive landscape and other development strategy tools

Target Product Profile (TPP)-based Development Strategy

We help design the drug/biologic/device development program on the basis of the label claims that you are targeting.  The utilization of Target Product Profiles (TPPs) assists in outlining the clinical program required, provide detailed information on risk and remediation strategies and provide choices regarding the likely marketing opportunities. A short presentation on the utility of TTPs is attached

Protocol Development

We can help develop protocols for all phases of development that would meet all the goals of your project

Clinical Operations Management

The successful management of clinical operations management is crucial for any program.  We can help you with the conduct of operations at any stage of clinical development. We can assist in the selection of CROs and other vendors, conclude agreements that would support the timeline and budget of your organization, coordinate CROs in a variety of countries (US, Far East, India, West and East Europe, Latin America), interface with clinical investigative sites, put specific guidelines in place to achieve reliable and accurate data collection and manage the overall program within the constraints of your timeline and budget.

Medical Writing

We can author or assist in authoring of protocols, investigators brochures, clinical study reports and integrated summaries of efficacy and safety

Clinical Department Quality Assurance

We can help evaluate the processes and procedures of the clinical department, analyze the gaps and develop and author standard procedures (SOPs), organize training to bring the department into full compliance

Due Diligence Assistance

We can help you assess clinical study reports and other clinical research documentation as well as relevant regulatory documentation and correspondence of products that you may be interested in acquiring or in-licensing.  We can perform the same tasks to identify potential gaps for products that you interested in out-licensing.