Potential
Clinical
Investigators
INTRODUCTION:
A. The Bracane Company is in the business of providing management of clinical trials.
B. Customer ( the research investigator) is willing and desires to retain The Bracane Company to obtain and manage clinical trials services.
RELATIONSHIP OF THE PARTIES
2.1 Non-exclusivity
2.2 Independent Contractors
BRACANE OBLIGATIONS
3.1 T he Bracane Company will secure clinical trials collaboratively with the investigator and sign the clinical trial agreement with the clinical trial sponsor.
3.2 Upon selection to participate in a clinical trial with a proposed sponsor we will complete and submit all pretrial start-up documents, maintain regulatory files.
3.3 We assist the site to develop trial management documents for the company in collaboration with the trial sponsor.
3.4 Assists with the development of a recruitment plan to comply with subject enrollment.
3.5 Offer training programs for the principle investigator and research staff on an ongoing basis for “Good Clinical Practice Guidelines” and Food and Drug Administration (FDA) code of regulations.
3.6 Provide research staff for the site to assist with trial procedures and management.
3.7 In the event of a
sponsor or FDA audit, we will provide assistance with preparation for of clinical trial documents or facilities if requested by a proposed sponsor or the FDA as needed.
What Does the Principle Investigator Have To Do?
4.1 The agree to participate and conduct proposed clinical trials according to FDA regulations and ICH guidelines.
4.2 Grant the company access to all necessary documents and the facilities to complete proposed protocol responsibilities for filing regulatory documents.
4.3 Maintain protocol records, screening logs and other required documents in accordance with FDA regulations and the sponsor requests.
4.4 Participate in training programs selected by the company for clinical trial management and FDA regulations.
4.5 Agree to maintain documents pertaining to the trial in according to sponsor request.
From Doc to Document: DictationNet Your Speech-to-Data Internet Super Highway
| Technology Matters It is time to take your medicine to the internet. DictationNet saves time and money while making transcription hardware, software and maintenance contracts
obsolete.
The Bracane Company offers a powerful and flexible dictation recording, storage, communication, transcription and management system for a cost-effective pay-as-you-go, per-line service fee.
Backed by millions of dollars worth of development and infrastructure, DictationNet has a full range of web-based functionality: - Reduced transcription and telephone costs
- No capital investment or maintenance fees
- Sophisticated management features
- Greater scalability and reliability
Benefits:
- Medical Records Managers benefit from detailed audit trails, making it easy to reconcile transcribed reports against supplier invoices and observe compliance with HIPAA regulations.
- Doctors benefit from improved turn-around times, receiving transcripts and any explanatory notes as soon as they are transcribed, eliminating system interface and job routing delays.
- The result is improved report accuracy, consistency and quality.
How the system works:
With DictationNet, clinicians dictate reports via toll-free telephone lines or a variety of digital handheld audio devices. By emulating the keypad controls of traditional recording systems, DictationNet ensures that no dictation behavior change is required.
Transcribed reports are normally printed at a hospital or clinic site, but DictationNet also lets you print, email, or fax copies to referring physicians. In addition, DictationNet provides a unique and powerful electronic version of the document with all fields tagged using XML, the new internet data tagging system, HL-7, the healthcare industry standard. Electronic documents are returned securely and formatted to predefined standards, allowing integration into Electronic Patient Records. This functionality saves time, avoids further processing costs, and maximizes the value of each report.
Secure, Sophisticated Web-based Network: Security is an immensely important aspect of DictationNet. DictationNet servers are housed in caged locked facilities with controlled access and CCTV monitors. Transcribed text is encrypted and routed through secure sockets (SSL) and HTTPS, making DictationNet fully compliant with all announced HIPAA regulations. DictationNet is a highly robust system. Servers are replicated around the world and located in data centers equipped with the latest air conditioning and environmental controls. Around the clock monitoring, redundant power supplies, and environmental
systems guarantee a full 24/7 service. Multiple independent high-bandwidth internet connections provide reliability of service and the capacity to handle millions of lines of transcription every
day. Backed by 24/7 support by phone and email, DictationNet servers can be viewed and controlled by authorized client staff around the clock. Our support organization uses the latest customer relationship management systems, providing
reliable technology and reliable service for your peace of mind.
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