TRIAL MANAGEMENT

BCR takes the onus of providing your study the most talented and experienced project managers in the industry. We serve you with a single point of contact for your project and place trained resources at the sites. We further keep on enhancing their skills with internal, customer-centric training ensuring truly unsurpassed service for our clients. Finally, we match your project with a project manager whose background and skills best match your requirements

 

Our project managers act as the link with the sponsor to ensure clear, concise communication and on-time performance every time. They are committed to maintaining flexibility and cost management. And as leaders of a multidisciplinary operational team, they are empowered to oversee every aspect of clinical trial management, handling changes and new objectives as they arise. Your project manager will be your single point of contact for every aspect of planning, coordination, compliance and operations

 

Our project management teams are supported by innovative clinical tools and systems, which provides a variety of reports with up-to-date study information. These customized reports enable project managers to anticipate the next step in the study process and proactively handle potential issues.


STUDY PLANNING

BCR understands that proper planning is key to conducting a successful trial. Our knowledge of the region, our specialty areas, and clinical research in general helps us spot potential trouble in the planning stages... and plan to avoid it.

 

Comprehensive feasibility questionnaires drive good planning. Without clear, comprehensive answers from the field, feasibility is just a guess. At BCR, we don't guess.

 

Our Site and investigator database is a powerful planning tool. We know where the patients will come from well before the study starts, so our sponsors know enrollment timelines will be met and the trial will start on time.


SITE SELECTION

We will search our extensive investigator/ site database for the right location, staffing, qualifications, history, clinical trial experience, area of therapeutic experience, GCP/ICH compliance and patient population/enrollment history. And as we have long-term relationships with these physicians, your study can start up quickly and smoothly.

 

We ensure efficiency at study start-up by providing a comprehensive binder to the site, detailing the required documentation for your study. We prefer to select clinical investigators we are familiar with to ensure fast turnaround for regulatory document processing and excellence in project execution.

 

People overachieve for people they like and respect. Sites overachieve for the same reason. So at BCR we focus on constant communication and training with our sites. It all pays off when these sites return on sequential studies, resulting in significant time and cost savings that we pass along to you.


GRANT NEGOTIATIONS

Traditional per patient fees get traditional results. At BCR, we often use more creative payment terms to motivate investigators and spur higher enrollment.

 

BCR has worked with most of the region's hospitals. That means there's a good chance we have previously negotiated a contract template we can use for your project. Our library of contract templates can save you the time and expense of starting from scratch.


SITE STARTUP

We provide expertise in each of the steps necessary to have a site up and running, including site specific strategies for prompt activation. Study startup objectives are both financial, by reducing the hours allocated to activate sites, and operational, by maximizing the time for patient enrolment and increased efficiency in processes.

 

Our focus on fast start-up has led us to develop processes which enables us to shorten the time taken to shorten the startup time. Standard operating procedures prepared by experts in the field along with simplified and continuous improvement techniques are being used to achieve efficiency and reduce the time for site startup. These processes pay special attention towards time taken for ethics committee submission and receipt of acknowledgement.

 

Further, our streamlined feasibility process enables us to reduce the startup time as we have signed confidentiality agreements and contracts with all the sites where we work. Whereas there is a provision to make specific additions as per the project to the contract.


SITE MONITORING

Great results require great commitment. To maximize our monitors' ability to focus on your study and produce the best results, we strive to assign them no more than two studies at a time.

 

BCR provides monitoring throughout India and South East Asia. Our decentralized workforce allows us to maximize flexibility, reduce travel costs, and create an efficient and cost-effective monitoring process.

REGULATORY & EC AFFAIRS MANAGEMENT

Any organization can read the local regulatory expectations, but only an experienced local provider can effectively help you with important details like modifying an Informed Consent to local standards in the many areas around our region. BRS knows which phrases are preferred by the Competent Authority and Ethics Committees, and which expressions will raise questions. More BRS projects are approved the first time -- avoiding time-consuming change requests.

BRS maintains a full and up-to-date collection of the local regulations and all the related legal documents. Local lawyers are involved in this process. This is a frequently changing legal environment – but BRS keeps pace better than any global CRO/SMO can.

As per the required formats for each site EC, BRS supports the submission of trial-specific documents for EC review and approval. This includes following the EC meeting schedule, requirements of each EC in terms of documents, formats and number of copies, covering letters etc. We ensure timely submission, presentation and tracking of approval letters, quality checks to ensure that the approvals/ letters are as per the local regulatory requirement.

If any aspect of your clinical trial application or project could be questioned by the authorities, we will always suggest a proactive consultation with them and manage it on your behalf. Being proactive with regulators avoids costly setbacks in the application procedure.


Every one of BCR Clinical Research Associates (CRAs) were carefully selected for their therapeutic expertise and clinical research experience. We seek out monitors with the best credentials in these areas because we know they are critical to the success of your trial.

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