Allphase Clinical Research Services
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| Allphase Clinical Research | |
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| Headquarters | US OFFICE:
33 Wood Avenue South, 6th Floor Iselin, NJ 08830 CANADIAN OFFICE: Gateway Business Park, 301-320 March Road, Ottawa, ON K2K 2E3 |
Contents
About Allphase
By utilizing our collective knowledge and experience in therapeutic development and medical affairs, we assist our clients in achieving great success with their development-stage programs and post-market initiatives. Diligent application of industry established best practices assures our clients that their projects are managed in strict compliance with industry regulations and laws. Our medical experts are cognizant of current and evolving standards of care to efficiently facilitate our clients with the development of their products. Allphase Clinical Research is a clinical research organization dedicated to Exceeding Your Expectations ®.
Allphase offers additional benefit that reaches above and beyond industry best practices and guidelines for the conduct of clinical research:
Well established policies, practices, and standards to maximize client value, ensure client confidentiality, and promote a healthy team environment • Experienced personnel with a solid foundation in clinical research, a disciplined work ethic, and an emphasis on client relationships • Long-standing relationships with premier clinical research institutions and therapeutic Key Opinion Leaders • Innovative, time-saving technologies such as our proprietary web randomization software and web-enabled document storage solution. • A personable, accountable, team-focused approach
History
Allphase Clinical Research is a full-service, progressive, Contract Research Organization (CRO) providing high quality clinical development strategy and management services for early-stage to post-market programs.
Allphase was founded with the mandate to become a highly trusted development partner providing intelligent, comprehensive and cost efficient options, and the highest quality product. We have achieved this through careful project team selection, a robust infrastructure, and a comprehensive understanding of the needs of our clients.
Therapeutic product development is risky business, but much of the risk can be averted by selecting development partners that provide expert-level knowledge, experience, strategy, and support, and of course, who have a track record of success. Allphase is dedicated to reducing the risks associated with therapeutic product development while enhancing the impact of marketed therapeutics.
Our highly effective team members are experts in drug development, regulatory requirements, and clinical trial management and have an unparalleled track record of success. Allphase is known throughout the industry for Exceeding Your Expectations ®.
Allphase Vision
Allphase Clinical Research is a full service CONTRACT RESEARCH ORGANIZATION dedicated to providing quality and service excellence to our pharmaceutical and biotechnology clients. Our core competency is clinical trial management services.
The company was founded on January 5th, 2001 to provide the highest quality service, exceptional value, and a better overall interactive experience for our clients.
Our vision is to be recognized as the number one preferred provider of clinical development services. We will exceed expectations through over-performance, transparency and professionalism.
To achieve this vision, we adhere to these principles:
Relentless pursuit of perfection. We continue to invest in a robust and supportive infrastructure to meet the needs of the most discerning client and employee. Our persistent development and refinement of standards and processes is designed to achieve the ultimate in efficiency and consistency.
Transparency. Our detailed proposals, fair pricing model, and accountability are what inspire confidence in our clients. Allphase has an exceptionally high repeat business rate, which is attributed to the high degree of trust our clients have in our abilities, and our business ethics.
No compromise. Our product is our service. To be the best we must employ the best talent this industry has to offer. Careful screening, ongoing performance reviews, and support provide an environment conducive to employee satisfaction and retention. Our personnel have a solid foundation in clinical trial management, a disciplined work ethic, and a focus on customer service.[1]
Allphase Services
Allphase Clinical Research provides clinical trial management, monitoring, medical writing, auditing, and related regulatory services to pharmaceutical and biotechnology companies. These are our core competencies and as such, they are executed effectively. The experience of our team has been consolidated to develop our organization as an efficient and user-friendly resource for our clients. To ensure that we continue to provide the level of service our customers expect, we regularly survey our clients and investigative sites for feedback.
| Allphase Clinical Research is positioned to provide the most value to our clients. We have an impressive infrastructure tailored to maximizing quality, efficiency, and support, without sacrificing responsiveness and flexibility. With a business model centered on flexibility, Allphase is your partner of choice. | ||||||
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Affiliate Services
Allphase Clinical Research is able to offer clients additional capabilities by augmenting our in-house services with those of our affiliated partners to be able to provide:
- Central Laboratory Services
- Investigational Product Distribution
- Home Health Care
- Ethics Review Board
- Translation Services
- Global CRO Network
Product Development Planning
The average cost to develop a drug from the screening process to market approval is estimated to be between 800 million and one billion USD. Approximately 75% of the overall cost of global drug development is consumed on products that fail. In addition, the time to market is approximately 10-12 years, with the majority of this time spent in the clinical development phase. Despite a larger understanding of numerous disease mechanisms, advances in technology, and regulatory initiatives, the number of new therapeutics reaching the market has not increased substantially over the past 10 years. 40% of potential lead candidates that enter into clinical development fail in the early phases. This significantly impacts the biotechnology sector where significant interest lies in early clinical phase partnership strategies. Furthermore, industry success in phase III studies has also decreased.
Taken together, these factors clearly express the risk involved in developing therapeutic products. It is therefore of high utility to employ strategic methodologies that are aimed at improving the success rate, shorten the development times, and decrease R&D spend.
Product Planning is critical to any organization, and a well-conceived and comprehensive Product Development Plan can provide a detailed assessment of your product and the most effective pathway to market, licensure, or clinical uptake. Allphase has expertise in providing qualified input for the planning and execution of the most successful strategies, the benefits of which have been realized by our clients with significant value being added to the project.
Clinical Study Management
The role of the Clinical Study Manager is critical to the success of every project. At Allphase Clinical Research, our Clinical Study Managers are experienced professionals trained to deliver superior service to our clients. Their collaborative approach combined with exceptional organizational and interpersonal skills creates a responsive client-driven environment.
Our services include:
• Study start-up;
• IND/CTA maintenance;
• Collaborative interaction with regulatory authorities and IRBs;
• Investigator site selection and feasibility assessments;
• Contract and budget preparation, negotiation, and administration;
• Investigator meeting organization and site training;
• CRA resourcing and mentoring;
• Monitoring report review;
• SAE reporting coordination;
• Coordination of site/ vendor/ client communications; and
• Managing client expectations for on-time and on-budget performance.
Clinical Monitoring
Our Clinical Research Associates (CRAs) are appropriately qualified and industry recognized for their outstanding reputation in customer service, in-depth knowledge of industry regulations and guidelines, and therapeutic knowledge. They ensure compliance with protocols, quality standards, data collection, and regulatory guidelines. The CRAs are regionally located across North America, reducing travel time and expenses. Our CRAs enjoy their profession, which we feel is ultimately reflected in their interactions with clients, colleagues and site staff as they perform their duties.
Our services include:
• Site selection, initiation, interim monitoring, and close-out
• Site personnel training, mentoring, and guidance
• Assessing protocol compliance and data integrity
• Regulatory document review
• Pharmacy training and drug accountability
• Ensuring GCP, consenting, confidentiality, and safety requirements are met
Data Management
Allphase Clinical Research offers a full spectrum of data management services and expertise to ensure the efficient and appropriate management of your clinical trial data. Our team is experienced in clinical trial design, implementation and execution at all levels. They are well trained and rigorously follow Standard Operating Procedures (SOPs) that encompass security, industry regulations, and GCP. Using state-of-the-art data management system technology, we always deliver a high-quality, unified database on-time.
Our services include:
• CRF and database design
• AE and medical coding and reporting
• Internet-based randomization (IWRS)
• Clinical trial safety database/ reconciliation
• Lab data import
• Single and double data entry
• Electronic Data Capture
• Query generation
• Data validation, storage and archiving
• Biostatistics
References
Career Opportunities
At Allphase Clinical Research, we continually strive to expand our knowledge base and experience by hiring talented people to further our remarkable growth. Our aim is to find the right people for the right roles to deliver services in line with industry best practices. Explore the careers at one of Canada’s fastest growing Contract Research Organization (CRO) dedicated to providing quality and service excellence to our pharmaceutical and biotechnology clients and their customers.
To view our exciting opportunities refer to open positions or submit your resume for future consideration here.
Why Join Allphase? Current Opportunities
At Allphase, we offer the opportunity to gain valuable work experience within a dynamic organization and the ability to have influence and impact. We provide a competitive compensation package and a comprehensive benefits program. To find out more about working with us, visit Why Join Allphase.
[3]- ↑ http://www.allphaseclinical.com/about/vision.aspx
- ↑ http://www.allphaseclinical.com/default.aspx
- ↑ http://www.allphaseclinical.com/careers.aspx
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