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END-TO-END CLINICAL TRIALS

Clinical trials are critical to the pharmaceutical, biopharmaceutical, nutraceutical, and medical device industries. These trials are used to test the safety and efficacy of drugs, therapies, nutritional supplements, and medical devices before they are released to the market.

ClinTrek provides end-to-end clinical trial services for:

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  • Pharmaceuticals- are drugs or medicinal products that are used to prevent, treat, or cure diseases and disorders.

  • Biopharmaceuticals- are drugs that are produced using biotechnology. These drugs are often used to treat complex diseases like cancer and autoimmune disorders.

  • Nutraceuticals- are nutritional supplements that are marketed for their health benefits. These supplements are regulated as foods rather than drugs, where the regulatory requirements for clinical trials are less stringent.

  • Medical devices- are devices that are used to diagnose, treat, or prevent disease or other medical conditions.

  • Diagnostics – are tests, devices, tools, techniques or methods of diagnosing or identifying illnesses or tracking prognosis in medical conditions.

Range of Services Offered by ClinTrek

Study Designing

Site Selection

Project Management

Centeralized Statistical Monitoring

Pharmacovigilance service through a partnered organization

Project Management

Clinical Monitoring

Patient Recruitment

Data management services through a partnered organization

Statistical Analysis

Pivotal Services

Bioanalytical
Support Services

Preclinical and clinical sample analysis, LC/MS/MS, GCMS, Spectroscopy,
Method development & validation, Certificate of Analysis (COA) etc.
through our partner organizations

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BA/BE Studies

To evaluate the rate and extent of absorption of a drug from a test formulation, through our partner organizations

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Phase 1

In healthy volunteers to determine the maximum tolerated dose or effectiveness of the device and/or any potential side effects, at government approved and licenced phase 1 units

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Phase 2

Group of patients with the targeted disease to determine a product’s efficacy, optimal dosage, the effectiveness of the device and/or safety

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Phase 3

In an even larger group of patients to confirm a product’s efficacy, the effectiveness of the device and/or monitor any rare side effects

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Phase 4

After the product or device has been approved and marketed, involves monitoring the long-term safety and efficacy of the product or device in consumers

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De-centralized trials

Clinical trials that use digital technologies and remote monitoring to enable patients to participate from their own homes or local healthcare facilities, rather than in a traditional clinical setting

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Real-world studies

Analysis of data from sources such as electronic health records, insurance claims, and patient registries to generate insights into the effectiveness and safety of medical treatments in real-world clinical practice

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Advantages of Working with ClinTrek

Expertise

A deep understanding of the clinical trial process and the regulatory requirements that must be met to obtain approval from regulatory authorities. With a team of experienced professionals, including clinical research associates, project managers, and data analysts, who are knowledgeable in their respective fields and in multiple therapeutic areas.

Quality at Core

Maintaining high standards of quality by attention to detail, a commitment to excellence, and a continuous improvement mindset.

Faster trial initiation

Initiate clinical trials faster by providing support for protocol development, site selection, and patient recruitment. This can save valuable time and resources and ensure that the trial starts on schedule.

Cost-effectiveness

Conduct clinical trials more cost-effectively by providing a range of services on a contract basis. This eliminates the need for companies to hire additional staff or invest in expensive infrastructure and allows them to scale up or down as needed.

Access to Technology

Experience in using advanced technology and tools that can improve the efficiency and accuracy of the data generated in clinical trials. This includes electronic data capture (EDC) systems, clinical trial management systems (CTMS), and statistical analysis software.

Risk Mitigation

A critical process that involves risk identification and risk mitigation on an ongoing basis to ensure that clinical trials are conducted in compliance with regulatory requirements and ethical standards. ClinTrek also supports risk management and safety monitoring throughout the trial.

Innovation by Design

Innovation in the clinical trial process helps in improving the efficiency, effectiveness, and patient-centeredness of clinical trials, ultimately leading to better health outcomes for patients. Without innovation, there can be no progress, and without progress, we cannot achieve our goals or bring about positive change.

Global Reach

Global network of partners and affiliates that can help conduct clinical trials in multiple countries. This can be particularly useful when seeking regulatory approval in multiple jurisdictions.

End-to-end clinical trial services are designed to ensure that the clinical trials are conducted in a rigorous and efficient manner, with the goal of completing the project within timelines at the highest possible quality.

 

Reach out to ClinTrek to achieve your product development goals.

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