Planning Clinical Study Success. Clinical trials are research tools to improve the medical treatment and even with the small step of improvement in the treatment is a lot significant to the patients. In fact the medical treatments received now are the result of clinical trial success then. Clinical operations are a critical component in all studies. Project planning and tactical execution are key solutions to accomplish the clinical trial operation. Initiating Sites: Firstly, identification and selection of potential site and investigators for trial greatly impact the quick subject enrollment, high-quality data and subject retention for any clinical study. Secondly, good feasibility analysis could be the preventive measure taken to avoid clinical study site failure to meet the statistically significant result in enrolment of patients. By avoiding redundant questions on details of investigative sites, buys time for discussion of more patient-centric questions. All along a quick response to IRB submission of the Study, regulatory documentation, preparation of source document templates, negotiation of budget and Contract provide a kick start to clinical trial. Several factors associated with Clinical Trial Agreement (CTA) could delay the clinical trial unless each is dealt in particular. Like poorly drafted agreement may result in inadequate confidentiality and intellectual property concerns or a troublesome contract negotiations may delay a clinical trial. Resources- A good motivation for all the clinical research stakeholders can trigger for better involvement in the study, towards the common goal. Most Investigators have strong desire to contribute to the development of medical innovation by their participation in clinical trials while others specified the financial remuneration. A clear communication between Sponsor/CRO and Investigative Site on specific elements of the protocol that might create challenges for patients’ enrollment must be discussed well before start of trial. A well organized study coordinator with eyes for details can run the trial smooth. Conduct of Clinical Study- Timely submission of trial documents for review, documentation of approved materials from EC is a step ahead in resolving the ethical issues in public. When monitor have an open channel communication with staffs, they become more approachable to monitor regarding any clarifications of the trial procedures or documentation and thereby reducing errors. Various protocol specific monitoring techniques, such as Target based monitoring system uses valid endpoints and focused objectives to maintain safety of patients and data credibility. We at Healing Hands Clinical Research Services (HHCRS) have established reputation providing quality work in clinical research Industry. We have collaborated with several multispecialty hospitals and potential Investigators, thus having access to large patient pool, quality data while keeping study timelines on target. Healing Hands Clinical Research Services, an SMO is the one stop solution to all clinical trial operation, focus on patient safety and ensure Clinical trial is carried out in highest standards of quality and ethics. SOPs are established and provide various communicative tools and strategies are followed for patient recruitment and retention. With experience of conducting trials in therapeutic areas of Oncology, Pediatric, Surgery, orthopedic, we can provide full support to clinical trial operations. We are also involved in herbal, cosmetics and nutraceutical trials. We have team of professional and dedicated clinical researchers who can manage and carry out all phases of clinical studies. Staffs implement the project plan, quality standards, maintaining quality data, patient recruitment, drug accountability and much more.
Posted on: Sat, 08 Mar 2014 06:54:07 +0000
Trending Topics
Recently Viewed Topics
© 2015