Clinical Operations Services & Products

  1. Clinical Operations

    Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.

  2. Risk Mitigation: Gap Analysis

    Global regulators are becoming increasingly vigilant in their oversight of clinical research, steadily increasing the annual number of Sponsor inspections they conduct. Sponsors that proactively assess process and organizational risks can act before these risks become findings in a regulatory inspection.

  3. Therapeutic & Diagnostic Product Strategy Development

    As products evolve and change, so does the expertise required to develop them. We work with the new and growing field of therapeutics and diagnostics that are combination products, typically comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic. These products can be physically, chemically, or otherwise conjoined to produce a single entity; packaged together in a single package; or labeled in such a way that both products are required to achieve the intended use or effect.

  4. Late Stage Clinical Product Development Strategy

    Our deep expertise in translational and clinical sciences combined with strong operational background allows us to evaluate each client's assets as unique commercial opportunities. We guide our clients through critical strategic decisions at product transition points, and help them manage partnerships or other collaborative alternatives.

  5. Biopharm & Medical Device Vendor Management

    In today's environment, companies are focusing on optimizing costs and as such, utilize external vendors frequently. However, with organizations increasingly dependent on multiple vendors to support product development, a disciplined approach to vendor management is critical for success.

  6. Organizational Design And Development

    Organizational optimization is one of our core offerings. We help clients redefine the vision for their company, restructure for a long-term and sustainable change, or build specific strategic and tactical capabilities to accomplish their product development objectives.

  7. Compliance & Regulatory Quality Systems Optimization

    An effective quality system is critical to compliant research and thus regulatory approvals.

  8. On-Demand Expertise/Interim Support

    Whether the objective is to build a fully integrated company or to create value in support of a liquidity event, talent requirements change over time.

  9. GCP & GLP Audit Services

    Whether you're looking to resource a single audit, develop or manage an entire audit program, or bring in an interim quality assurance manager to support your team, Halloran provides experienced, cost-competitive, and responsive quality and compliance services for Good Clincal Practice (GCP) and Good Laboratory Practice (GLP). 

  10. Strategic Resourcing Functional Services

    Our dedicated functional teams have the experience to be your partner in clinical research. We deliver a variety of clinical development services customized to fit your objectives, whether you need a single function across several drug programs, a range of functions within a single therapeutic area, a complete staff lift-out or any other defined need.