RESEARCH TO REALITY

Bridging the Gap Between Science and
People.|

Technology Transfer

Bringing research to reality by providing a time tested preclinical and clinical trial technology transfer platform.

Quality

Providing full support of compliance and regulatory requirements for cell therapy products.

Auditing

Auditing of the clinical space and procedures followed.

Analysis and Support

Continued analysis and support throughout the clinical trial process of the product.

FDA Communications

Facilitating and initiating FDA communication throughout the trial process.

Cost Analysis

Estimated cost analysis of the trial process for products, instruments, staff, and GMP facility.

There every step of the way

The Etra Clinical Process

The etra clinical process explained.

Step-1

Research & Translational Studies

Product safety, comparability to preclinical material, feasibility of process. Increasing expectation for product characterization and compliance with cGMP.

Etra's Expertise

The Etra team has a tested and optimized technology transfer platfom. Additionally, the teams experience with translating clinical research to treatments for patients helps our clients identify significant gaps in their process at a much early stage than traditional clinical trial methodologies

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Step-2

Pre-Clinical Studies

Scale up/out to support clinical studies.

Etra's Expertise

Etra collaborates with researchers and experts in the field to create highly specialized and concise study plans. Etra utilizes rigorous experimental methods to ensure accuracy and reliably of your data for future regulatory submissions.

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Step-3

Clinical Studies

Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects.If a new treatment is found to be safe in phase I clinical trials, a phase II clinical trial is done to see if it works in certain types of cancer.

Etra's Expertise

Etra has significant experience developing and validating manufacturing protocols which are successfully used by multiple manufacturing sites across the country. Etra collaborates with regulatory agencies to ensure the clinical process meets the latest manufacturing standard.

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Step-4

Commercialization

Full FDA compliance required. When phase III clinical trials (or sometimes phase II trials) show a new drug is more effective or safer than the current treatment, a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval.