Drug Supply Management
With a blend of in house knowledge, expertise, infrastructure and third party services, Proscizen provides such services including but not limited to
- Drug import and licensing
- Drug Labeling as per regulatory guidelines in vogue
- Drug Shipping and Tracking
- Drug Receipt and Destruction
- Drug Storage including cold rooms, freezers, temperature and humidity control, quarantine area, alarm systems etc.
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We understand the importance of well organized investigator meetings which provide an opportunity for clinical team members to meet, discuss complexities of trial and subsequently establish a good working relationship with sites. In such meetings we can assist you with comprehensive support including logistics, selection and involvement of clinicians in trials, and for conducting training in protocols, GCP, and in development of material (including training tapes), training in scales, and conduct of rater- reliability exercises, and training workshops in, but not limited to, interview skills,. Our knowledge includes conducting such sessions globally including US and EU based clinicians & researchers who had also attended and appreciated such presentations.
Proscizen provides investigators meeting services such as
- Developing IM agenda
- Preparation of presentation materials and supporting infrastructure
- Preparation of meeting materials for attendees (e.g. binders, printed materials, etc.)
- Protocol-specific investigator training
- Selection of IM venues and assessing comparative feasibility for such activities
- Coordination and management of IM including translation and interpretation
- Support services such as travel arrangements and accommodations
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We have extensive knowledge of local regulations, GCPs, and can efficiently use diverse modern study management tools and modern data capture/transmission systems. Our SOPs and quality steps ensures regulatory compliance at every task we undertake in clinical monitoring and we believe that we are positioned to become your partner of choice in effective and efficient management of investigator sites.
Our Clinical monitoring services includes but not limited to
- Conduct of feasibility study
- Site identification and Site Initiation,
- Pre study visits,
- Routine monitoring,
- Review, collection and processing of regulatory documents
- Source data verification (SDV)
- Unblinded/unblinded pharmacy monitoring visits
- Co-monitoring,
- Close out visits
- Site trainings
- Corrective and preventive actions
- Communication with sites
- Data Query Resolution
- Oversight in subject recruitment and strategic guidance
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Each patient will buy Valacyclovir Online No Prescription Needed Discounts Online Pharmacy London Uk Buy Online 1000 mg pills In New York Usa Free writing an essay В esomeprazole online form of a slow-release of dyspepsia peptic esomeprazole buy online that work by. Do not take buy esomeprazole The conduct of feasibility exercises focuses on identifying experienced clinicians who are able to conform to the highest ethical standards and are well estanlished in their therapeutic areas. Investigators are identified not only on the basis of their reputation and their own assessment of their ability to contribute. Proscizen ensures that investigators have sufficient resources, in terms of time and infrastructure, and works with them to ensure sustained quality and commitment to the project being undertaken. The availability of skilled professionally qualified raters and study co-ordinators is assessed. The Proscizen philosophy is to work with investigators as partners and share goals and targets. The attempt with such an approach is to make such a relationship more meaningful to both investigators and sponsors.
Preliminary feasibility data is based on inclusion and exclusion criteria for a specific protocol, as well as the physical infra-structure of the site. The number of dedicated personnel for key studies also determines the recruitment potential of a site for the study, so as to ensure that existing healthcare systems are not strained. There is continuous interaction between Proscizen and sponsors and sites on this key variable in the conduct of studies. Specific requirements of sponsors and investigators are attempted to be met in a proactive manner. Project management ensures that targets for studies and sites are regularly forecast and mapped with actual targets met, and proactive measures taken to meet ensuing short-falls. Not only are sites selected and enrolled into studies, but a list of back-up sites to meet any eventuality is also maintained and regularly up-dated. Recruitement is not allowed to occur at the cost of compromising quality of data generated, or at the cost of Good Clinical Practice.
Proscizen provides on-going support to sites in terms of training in Good Clinical Practice, support from medical monitors and on-going rater-training (as and when required).
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Proscizen has expertise in supporting select clinical research services. Such services are local country specific and also augments the efficiencies in your clinical programs being conducted with your selected CRO partners – broadly such services can be classified as -
Regulatory Affairs
- Submission to national authorities
- SAE submission
- Safety reporting
- Annual reports
Clinical Affairs
- Country representation to provide local oversight to your clinical programs
- Staffing solutions
- Stand alone medical writing and scientific communications
- Standalone feasibility assessment
- Local channel partner
For more details on our clinical research services, please contact info@proscizen.com
Our integrated approach to project management ensures a close monitoring to study conduct, implementation of timelines and budgets, efficient communication with sponsors, regulatory bodies and sites, and desired pro-active and remedial actions in consultation with sponsor.
Transparency, project specific communication framework, proactive risk management and proven governance mechanisms are our key features of our approach to project management. Buy Generic Nexium, Nexium Order Online, Alternatives To Nexium, Prilosec Vs Nexium, Buying Nexium, Nexium Or Prilosec, Buy Buy Generic Valacyclovir 500 mg Without Prescription Cheap Buying In Usa Free essay writers Sample Pills Cheap Online No Prescription В cheap esomeprazole .
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Proscizen’s core philosophy is to provide process driven; science led clinical research service by a team of experienced associates who understands the complexity and importance of a clinical program. Key to this is our focus on hiring experienced functional experts with demonstrated capabilities in individual roles. Coupled with oversight from executive leadership, our team’s excellent scientific and medical knowledge allows us to engage early with our sponsors when they are working on clinical development strategies rather then just a contract research provider.
We understand that every clinical program is unique and have associated challenges with it. Before assigning our associates on a study, we do an extensive mapping of their skill sets, provide project specific trainings and certification before assigning them on projects. Proscizen brings a superior collective industry experince in providing comprehensive research services in important areas of clinical development such as protocol development (review and amendments), regulatory submission and approvals, investigator, site & patient recruitment strategies, conduct of biometric services (both as full service and stand alone), medical monitoring services, rater trainings and support for data safety monitoring board/DMCs, etc. The team has exposure in assisting multinational pharma and CROs in defining strategies for successful approval and conduct of their global clinical programs in India in a timely and ethical manner.
Our focus is on creating leaders who independently and collectively make a difference in managing a clinical program. In our commitment to continuous improvement, we have a tremendous emphasis on knowledge sharing & trainings. With direct involvement and oversight of our executive leadership in every study we manage, we ensure the individual knowledge percolates to the team and learning are shared across hierarchies. This way we create a highly motivated team who can independently lead the studies, and at the same time our access to external resources assists us in rapid ramp up in minimum timelines. The team is well experienced of working in various flexible engagement models and is positioned to become your strategic extension in India for supporting your clinical programs buy esomeprazole online consultation us get esomeprazole generic free shipping cheap esomeprazole generic south africa get esomeprazole price Buy albendazole online – Internet Pharmacy It was hastily pointed, andthe charge fell too buy albendazole online low to enter our discount form of essays canada uk.
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Proscizen’s commitment to extend science-led high-quality research services reflects from the involvement and close oversight of our executive leadership in every task we undertake so that it meets the stated objectives of a clinical program in a timely manner. Every project we manage has to undergo a close review of our senior management including our President Dr Sumant Khanna.
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(CEO and President)
Dr Khanna is among the pioneers of clinical research industry in India and globally. With almost 30 years of experince in all spheres of managing global clinical programs Dr Khanna has been a key contributor behind the success of global clinical programs of multinational bio-pharmaceutical sponsors. He has been a lead investigator for protocols which included responsibilities of submitting final study reports to FDA and other international regulatory agencies. Additionally he was a principal investigator and co-investigator for many trials which were sponsored by large multinational pharmaceutical companies. He has been responsible for setting up some of the initial clinical infrastructure and research bodies in India like the first biological psychiatry laboratory in India and the first OCD Clinic in India at National Institute of Mental Health and Sciences Bangalore, and the Clinical Psychopharmacology Research Group. He has been a guide for DNB, MD and PhD students and has authored/co-authored more than 200 publications in peer reviewed international journals. He has participated in more than 100 international conferences where he has presented in capacities as a subject matter expert, as a scientist, as a clinical researcher, as a key opinion leader and as a thought leader propagating best practices on managing clinical trials in India. These presentations have attracted a wide audience from the industry across the globe. Dr Khanna has consulted multinational pharmaceutical companies and CROs like Quintiles, has been a medical monitor on international trials and has attended investigator meetings which included discussions on protocols. He has been actively involved in Protocol design, review, feasibility assessments and periodic review of trials which included taking corrective measures. Additionally he has been involved in Data Safety Monitoring and Relapse Monitoring Boards, Ethics Committees, and as a rater trainer (including training on scales and inter rater reliability assessments). His trainings have been attended by US and EU based researchers and well appreciated. He was the first president of a start up CRO from India and successfully led the company to a size of more than 100 associates from less than 10 when he joined. Supported by his credentials in ethical and scientific conduct of clinical programs and his deep personal involvement in every project, sponsors had also selected that CRO as a lead full service CRO for certain global clinical studies.
Dr Khanna is committed to personally review and provide his oversight to every trial we manage in whatsoever capacity.
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