ICE Global Consulting Clinical Trial Attorneys Agreement Expeditors
About ICE Global Consulting Clinical Trial Attorneys
ICE Global Consulting is a globally experienced consulting firm in North Carolina specializing in the accelerated startup of clinical research trials by handling the contract drafting and finalization. We manage clinical trial contracts, clinical trial budgets, and clinical trial site investigation to ensure you get Fair Market Value for your clinical research. ICE works directly with clinical research organizations to provide assistance with contract drafting and negotiation, negotiation strategy, consulting, and training and coaching for clinical trial processes.
Clinical Research Trials & Agreement Process
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. The research studies are performed by pharmaceutical, biomedical, biotechnology or medical device companies with the goal of understanding the positive and negative effects of a new drug or treatment. These companies seek to learn whether the new drug or treatment is both safe and effective before it is released to the public in order to avoid detrimental effects within the population such as side effects or death. Some trials set out to determine if there is a way to detect the onset of diseases before they occur, which are highly important and effective prevention studies. These studies are highly regulated, and each trial must go through rigorous scrutiny to become Federal Drug Administration (FDA) compliant before it is approved.
Phase I clinical research trial
Tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
Phase II clinical research trial
Uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
Phase III clinical research trial
Gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
Phase IV clinical research trial
For drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
The Phases of a Clinical Research Trial - 4 four main stages
What is a Clinical Research Organization (CRO)?
A Contract Research Organization, or CRO, is an organization hired by a company in the medical field to manage the company's clinical trials and perform other tasks to help bring a drug or device to the market. CROs typically contract with companies in the pharmaceutical, biotechnology, or medical device industries, but their clients also include governmental institutions, foundations, and universities. These organizations contract with CROs to acquire the specific expertise needed to carry out trials safely and efficiently without hiring permanent staff. CROs have become vital to the clinical trial process, as outsourcing the work needed for the studies are time and personnel intensive, and can oftentimes be too much work for the company that has developed the drug or treatment to carry out themselves.
- Biological and chemistry expertise
- Formulation assistance
- Project management
- Database design and build
- Data entry and validation
- Clinical trial patient recruitment
- Clinical trial data management
- Medicine and disease coding
- Quality and metric reporting
- Statistical analysis plans and reports
- Validation programming
- Safety and efficacy summaries
- Study report evaluation and submission
- Marketing assistance
Types of Clinical Research Organization Services
Examples of Clinical Research Organizations
- Laboratory Corporation of America Holdings
- Syneos Health
- Parexel International Corporation
- PRA Health Sciences
- Pharmaceutical Product Development
- Charles River Laboratories
- WuXi Apptec
- Medpace Holdings
Many CROs are located in or around research triangle park north carolina nc
Benefits of Clinical Research Organizations
Reduced need for staffing or infrastructure upgrades
Contracting with an outside company means that the sponsor doesn't need to acquire the manpower, infrastructure, or office space to carry out drug or device design, development, and testing themselves. This characteristic is particularly beneficial for smaller firms who may otherwise find it difficult to recruit the specialized talent needed to bring a new product to the market.
Faster clinical trials
CRO trade groups claim that when firms or public entities outsource to a CRO, it reduces the time it takes to conduct a trial versus doing it in-house, translating to a faster time-to-market.
Lower costs without shrinking profits
As pharmaceutical and medical devices organizations face increasing pressure regarding high drug costs, they continue to seek ways to lower prescription drug costs without losing profits. Outsourcing clinical trial management to CROs is one way for these companies to significantly lower overhead costs, helping them recoup the money they might lose by reducing drug prices. Faster clinical trials can also help reduce costs.
What do ICE global consulting attorneys do for your CRO?
Reduced Contract Approval Time For Clinical Trials
We have site-specific knowledge and global contract templates that expedite the negotiation process of having clinical trials approved in other countries. We employ comprehensive contract strategy and planning based on prior knowledge to help foresee and prevent issues and avoid delays associated with clinical trial approval, as well as navigate budget and contract hurdles. Our negotiators use widely accepted terms within our contracts that facilitate site-specific approval based on historical data at that site. We use mCTA which accelerates the multi trial collaborations and long term partnerships between sites and Clinical Research Organizations.
Globally Prepared Clinical Trial Agreements
ICE Global understands the complexities and challenges of navigating the contract negotiation process across regions and countries, with differing languages and cultures. We are prepared for success by utilizing our cultural and language-conscious approach in over 60 countries. We have an extensive clinical trial agreement template library to facilitate quicker approval times that leverage past experience in these international territories, by region, country, and site. ICE is always prepared with fallback language in the case that chosen contract wording is questioned to swiftly stay on track with the approval deadline and avoid setbacks. We are consistently monitoring changes and updates to foreign, national, and local laws that regulate clinical trials so we can stay ahead of the curve and ensure that CROs are never delayed by these changes.
Extensive Trial Site Intelligence
We use industry standard benchmarking software in conjunction with historic site knowledge to quickly develop a site budget that achieves Fair Market Value (FMV). Our highly trained budget developers are spread across a multitude of commercially available tools that reduces the review time required by trial sites. Your budgets will be tailored to your needs by industry, region, and needs.
An experienced global team focused on strategically navigating clients through the clinical contracting process.
ICE Global offers a team of skilled lawyers and other contract professionals with extensive experience in clinical research to effectively navigate the contract and budget development process. We assist our clients in expediting global negotiations and provide the support needed to efficiently manage high volumes of work with tight timelines. Our team serves as operational delivery partners who provide assistance with contract drafting and negotiation, negotiation strategy, consulting, and training and coaching within a multitude of functional divisions within our clients’ organizations.
Time Is Of The Essence
ICE Global brings a highly skilled team of global negotiators with the experience and site-specific knowledge to expedite clinical contract negotiations. We understand site expectations and assist our clients with establishing strategies for working with the institutions to expedite the negotiation process.
- Our team leverages prior knowledge to address likely budget and contract hurdles
- Strategy and planning help to foresee & prevent issues to avoid delays
- Negotiators use historically accepted contracting terms to facilitate ease of review by sites
- mCTA for accelerating multi trial collaborations and long term partnerships with sites
ICE Global understands the complexities and challenges of navigating the contract negotiation process across regions and countries, with differing languages and cultures. We are prepared for success by utilizing our cultural and language-conscious approach in over 60 countries.
- Extensive library of contract templates by region, country, and site
- Fallback language and pre-approved negotiation parameters prevent costly setbacks
- Use our knowledge of country-specific regulations to optimize timelines and strategies for contract execution
- Monitor changes in clinical research and local laws and regulation to stay ahead
Our team leverages historic site knowledge coupled with industry standard benchmarking software to quickly develop a site budget that achieves fair market value.
- Extensively trained budget developers across a multitude of commercially available tools that reduces the review time required by sites during the negotiation process
- Budgets tailored by therapeutic area and indication in over 60 countries