Clinical Operations

Developing profitable treatments is not an easy process, and between increased regulations, aggressive competition, and desperate demands for innovative treatments, it is only becoming more difficult.

We help pharmaceutical companies manage the challenges associated with getting products to market. Our consultants have deep experience with every stage of the most complicated clinical studies.

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Clinical Trials and How We Achieve Success

A high-complexity clinical trial is an exercise in balancing contradictory mission-critical tasks. How do we get to market quickly without sacrificing safety? How do we innovate while ensuring compliance, complete extensive clinical trials economically, and focus on the science behind effective therapies while productively managing teams? The solution to these problems, and the key to competitive, safe, and effective development, is partnering with an experienced solutions provider who can help you fill the gaps in your team, mitigate blind spots, and avoid roadblocks.

Today, pharmaceutical and biotechnology companies simultaneously face an increasingly strict regulatory landscape and an unprecedented demand for novel medicines, particularly in biologics and rare disorder therapies. As you attempt to scale up, meet compliance requirements, and improve delivery metrics, support from knowledgeable partners is necessary. EG Life Sciences offers decades of experience and industry-leading proficiency to help drive the minute yet integral aspects of clinical development and operations.

EG Life Sciences specializes in supporting Clinical Operations by providing professional industry experience to address clinical skill gaps across clinical development and operations.

Our Core Competencies

Our core competencies within Clinical Operations include the following areas:
  • Biostats
  • Cellular & Gene Therapies
  • Change Management
  • Clinical Evaluation Reports (CER)
  • Clinical Compliance
  • Clinical Research (including CRAs)
  • Clinical Trial Management (All Phases)
  • Chemical, Manufacturing, and Controls (CMC)
  • CRO & FSP Outsourcing and Management
  • Medical Affairs
  • Medical Writing
  • New Drug Development (Small and Large Molecule)
  • Pharmacometrics
  • Pharmacovigilance & Medical Safety Pipeline and Portfolio Management
  • Sr. Program and Project Leadership and Management (All Therapeutic Areas)
  • Pre-Post Market Surveillance
  • Quality Management Systems (QMS) Harmonization
  • Regulatory Affairs Leadership and Support
  • Statistical Analysis Software (SAS) / Statistical Programming
  • Study Response Physicians
  • Translational Medicine
  • Veeva Vault and other LS Content Management Systems

Global Program Management for Rare Disease

Clinical researcher highly skilled in rare diseases helps complete studies to submit for final FDA approval.

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How do we deliver scalable and flexible solutions?

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