Outsourcing
The utilization of Clinical Research Organizations (CRO’s) and other Service Providers by Biotech and Pharmaceutical Companies (Sponsor) is becoming standard with regard to drug development because of the lack of expertise, not enough resources and lack of understanding of the country culture at many Biotech and Pharmaceutical companies.
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Pharmacovigilance (safety)
Pre-Clinical
Many Investigational drugs do not make it on the market or even to clinical development because of a poor safety profile. The pre-clinical stage of development is critical to submitting Investigational New Drug (IND) application for FDA approval. An IND must contain Animal Pharmacology and Toxicology Studies data in order to assess whether the product is reasonably safe for initial testing in humans. The FDA regulations that pertain to the requirements of an IND application start at 21 CFR 312.20. The guideline in Europe is ICH Topic M3 (r2) Document "Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals".
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GCP Compliance in Clinical Trials
There are many important areas of compliance to consider when conducting clinical trials. Although, patient and investigator compliance are important determinants in the outcome of clinical trials and have been discussed at length, less attention has been spent on the Sponsor’s compliance with regard to running clinical trials. Good Clinical Practice (GCP) is the standard that should be followed by the Sponsor and the Investigator when conducting clinical trials.
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Clinical Services: A Snapshot
For the emerging Biotech company ready to initiate a clinical trial, Clinical Operations is a valued commodity not to be misjudged. It is one of the significant priorities that management should focus on in today’s regulated environment.
Clinical Operations are the activities associated with the initiation, maintenance, and close down of a clinical trial. This seems pretty simple and straightforward, however, there are critical issues every company should think about as they move to the clinic. These issues include but are not limited to the following,
Two Technology Solutions to Streamline
Clinical Development
In an age where clinical development of a drug or device from clinical trial initiation to commercialization is costly and time consuming for a company, a forward thinking strategy should be a priority and thus, implemented. The strategies and technologies that have been under utilized in clinical development are electronic tools, such as electronic data capture, data analysis software and electronic patient diaries. These tools will undoubtedly streamline the clinical development process and result in long term efficiencies.
Read the entire article
The utilization of Clinical Research Organizations (CRO’s) and other Service Providers by Biotech and Pharmaceutical Companies (Sponsor) is becoming standard with regard to drug development because of the lack of expertise, not enough resources and lack of understanding of the country culture at many Biotech and Pharmaceutical companies.
Red the entire article
Pharmacovigilance (safety)
Pre-Clinical
Many Investigational drugs do not make it on the market or even to clinical development because of a poor safety profile. The pre-clinical stage of development is critical to submitting Investigational New Drug (IND) application for FDA approval. An IND must contain Animal Pharmacology and Toxicology Studies data in order to assess whether the product is reasonably safe for initial testing in humans. The FDA regulations that pertain to the requirements of an IND application start at 21 CFR 312.20. The guideline in Europe is ICH Topic M3 (r2) Document "Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals".
Read the entire article
GCP Compliance in Clinical Trials
There are many important areas of compliance to consider when conducting clinical trials. Although, patient and investigator compliance are important determinants in the outcome of clinical trials and have been discussed at length, less attention has been spent on the Sponsor’s compliance with regard to running clinical trials. Good Clinical Practice (GCP) is the standard that should be followed by the Sponsor and the Investigator when conducting clinical trials.
Read the entire article
Clinical Services: A Snapshot
For the emerging Biotech company ready to initiate a clinical trial, Clinical Operations is a valued commodity not to be misjudged. It is one of the significant priorities that management should focus on in today’s regulated environment.
Clinical Operations are the activities associated with the initiation, maintenance, and close down of a clinical trial. This seems pretty simple and straightforward, however, there are critical issues every company should think about as they move to the clinic. These issues include but are not limited to the following,
- Maintaining Good Clinical Practices and Regulatory Compliance
- Data quality; how is the data reviewed and captured, is internal review conducted
- How many clinical sites; domestic and/or outside of the USA
- Timeline and cost
- Go No Go decision
Two Technology Solutions to Streamline
Clinical Development
In an age where clinical development of a drug or device from clinical trial initiation to commercialization is costly and time consuming for a company, a forward thinking strategy should be a priority and thus, implemented. The strategies and technologies that have been under utilized in clinical development are electronic tools, such as electronic data capture, data analysis software and electronic patient diaries. These tools will undoubtedly streamline the clinical development process and result in long term efficiencies.
Read the entire article
