Clinical Research Services

MANGALORE CLINICAL RESEARCH FOUNDATION
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We are a Site Management Organization with the best network of medical professionals in and around Mangalore  whose sole purpose is to support the successful outcome of clinical trials for the pharmaceutical industry. Our goal is to earn the recognition as a company that provides our customers with unparalleled service, responsiveness, and results. We continually strive to be the finest resource for you and to ensure that we satisfy your specific and unique needs.
Established in 2007 it was previously an epicentre for clinical research in neurology and psychiatry and has  presently expanded to all specialities. Our network of highly qualified, capable, and dedicated Investigators now number in excess of 100 medical professionals representing virtually all speciality areas. It is not just the strength and commitment of our Investigators that is the foundation of our success, but the experience and dedication of the Clinical Research Coordinators assisting these physicians in the preparation and conducting of these trials.
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What We Do


We present qualified, pre-screened, Principal Investigators for participation in clinical trials in virtually any speciality area.

We have developed effective and stable relationships with many highly experienced, qualified and enthusiastic Clinical Investigators and Clinical Research Coordinators throughout the Mangalore. This includes single practitioners, large single and multi-specialty practices, physician networks, hospital based physician's, and academic medical centers. All of the Investigators within the MCRF network have been evaluated to ensure they not only are qualified to conduct clinical trials, but have the patient population and administrative capabilities to properly conduct it. They must meet specific minimal standards before being included in the network.  We only present those Investigators meeting the specific selection criteria outlined by the Sponsor or CRO. This eliminates a significant amount of time and expense when attempting to qualify, enroll, and initiate a site.

We ensure timely and accurate regulatory board submission and data collection
All sites will have dedicated, full time, and experienced clinical research coordinators to ensure the prioritized and accurate submission of regulatory documents, appropriate site orientation/initiation, patient recruitment, screening and enrollment as well as the collection of clean and accurate data. Our own internal management and quality assurance practices further assures that tasks are completed quickly and accurately and any problems that jeopardize the success of the study are quickly identified and resolved.


We provide access to a large patient study population
Prior to us presenting an Investigator for study participation, we assess the patient population from which study subjects will be drawn to assure the increased likelihood of enrollment goals being met. Although we believe that carefully orchestrated advertising can assist in meeting enrollment goals, we firmly believe that the site must have the patient population or internal referral base from which to enroll patients.

We provide ongoing and effective communication between Sites, Investigators, and Customers
The cornerstone of any successful clinical investigation is ongoing support and communication between all parties. Because of our commitment to the successful outcome of every study in which we participate, an internal Project Manager is assigned to each study to ensure that communication is maintained and that the study receives the full attention it deserves until completion. There are undoubtedly numerous variables and situations that arise during the conduct of a study that could compromise it’s outcome, and this demands a professional with expertise, strong problem solving skills, and attention to detail to overcome those obstacles. We provide that experience.

We continually strive to be the finest resource for you and to ensure that we satisfy your specific and unique needs.

Mangalore Clincal Research Foundation Highlights:

  • Ability to provide multiple, quality sites with one phone call
  • Ability to conduct Phase II through Phase IV studies
  • Large database of highly skilled, experienced and enthusiastic Investigators
  • Dedicated, full time, and experienced Clinical Research Coordinators 
  • Efficient and centralized contract and budget resolution
  • Ability to conduct inpatient and outpatient studies
  • Strong working relationships with local and central IRB’s and laboratories
  • Established and stable relationships with large public, private institutions
  • Through Swift enrol service, provide emergency or replacement sites within 72 hours or less.
  • Track record of consistently meeting or exceeding enrollment goals
  • Aggressive patient recruitment program to support local site’s own efforts
  • Proven ability to successfully conduct even the most challenging of studies
  • Stable, effective and mutually beneficial working relationships with Investigative sites.


MCRF
can provide Investigative Sites with a myriad of services to assist in the establishment of a new clinical research component to an existing practice as well as provide services that can strengthen and increase the core capabilities of the Site and personnel. Rather than trying to sell you services you may not need, all of our services are customized specifically to the needs of the Site.


Our Specialities:

Sponsor/CRO:
Thank you for your interest in considering MCRF. to assist you in your efforts to bring cutting edge therapies to the marketplace. We take very seriously your mission and are committed to do all that we can to ensure the successful outcome of your clinical investigation. Please contact us to discuss how we may be able to work with each other.

Our bottom line goal is to provide you with ethical, quality oriented, enthusiastic, and experienced clinical research sites in an expedited and efficient manner. Whether you are managing your trial internally or utilizing the services of a Contract Research Organization, we can help speed up the site identification, qualification, initiation, budget/contractual negotiations and start up process. Our internal management and operating procedures are specifically designed to quickly provide you with multiple and highly qualified sites that meet your specific criteria. Because we only present those sites that meet your self-defined needs, you can significantly reduce the time and resources required to evaluate and qualify a site or Principal Investigator.

We assign a Project Manager to your study to assist with early centralized communication. This increases efficiency by reducing the time you typically spend answering similar site generated questions.

We have excellent working relationships with many quality CRO's. Because of these established relationships, communication is greatly enhanced. Additionally, because the CRO may have previously worked with a particular site, they are familiar with its capabilities and past performance. This can significantly reduce time and resources expended during the site identification and qualification process. Having an established relationship between the monitor and site can also reduce monitoring time and expense.

Quality:
All of the Investigators in the MRCF network are highly experienced clinicians and researchers.
Clinical Research Coordinators must also meet stringent criteria. Since we place an enormous amount of responsibility for the success of your study on them, we ensure that they have the skills and capabilities to manage it appropriately.

Efficiency:
Since we utilize our database to identify investigators based on your specific criteria, a significant amount of your time and resources are saved during the initial site identification, screening, and qualification of our investigators.

Because of our ability to present multiple sites, one call to us can assist you in selecting numerous investigative sites. We do not believe in the all or none philosophy. You are always free to select only those sites that you want to use. All sites must (and do) demonstrate their own merit for selection and do not expect to be chosen just because they are part of the network.

Budgetary and contractual discussions are always centralized, thus minimizing lengthy negotiations for each site. Upon agreement of a budget (which is applicable across all sites), a clinical trial agreement can typically be executed within one week or less.

Although all of our services are customized to the specific needs of the Site, the following is a representative sample of solutions we have provided in the past.

Trial Management---------- Study Design and Protocol Development

• Complete literature review and meta-analysis
• Statistical planning (sample size estimation, randomization, and power calculations)
• Case Report Form (CRF) design and guidelines to fill-in
• Informed consent form (ICF)

Trial Management--------- Pre-study Site Preparation

• Site feasibility studies
• Site selection and evaluation
• Collection of essential documents
• Investigators’ meetings
• Documentation procedures, such as Trial Master File Management, central investigator file and investigator site file
• Investigator Grants Management

Trial Management---------- Site Initiation and Training

• Staffing with trained and experienced CRCs
• Patient recruitment support
• Investigational Product (IP) Management
• Training on IP, lab handling procedures, ECG, etc.
• Logistics management
• Site specific Standard Operating Procedures (SOP's)
• On-site developmental briefing of Investigators and research team
• Customized Programs in:
- Working and interacting with Regulatory Authorities.
- Effective informed consent processes for subjects
- Regulatory document preparation and maintenance
- Current industry standards (GCP, GLP)
• Maintenance of CRFs, Informed Consent Forms (ICF) and study logs
• Prompt entries into Electronic Data Capture systems
• Drug accountability and central laboratory Interactive Voice Response System (IVRS) and ECG procedures
• Preparation for audits
• Business Development of the Site and its capabilities
• Notification of upcoming research trials and opportunities
• Provide expertise in customized budget preparation
• Ethics committee approval, DCGI clearance

Trial Management---------- Site Monitoring

• Patient follow up
• Tracking CRFs
• Regulatory compliance
• Site Quality Assurance
• Maintenance of Site documents
• Resolution of queries
• Research site liaison
• Progress and status reports
• Resolution of issues like Serious Adverse Event and DCFs within timelines

Trial Management---------- Study close out

• Patient follow up
• Tracking CRFs
• Regulatory compliance
• Site Quality Assurance
• Maintenance of Site documents
• Resolution of queries
• Research site liaison
• Progress and status reports
• Resolution of issues like Serious Adverse Event and DCFs within timelines

Site Management
  • Site specific Standard Operating Procedures (SOP's)
  • Quality Assurance
  • Audit Services
Site Business Development and Promotion
  • Notification of upcoming research trials and opportunities
  • Marketing and business development of your site and its capabilities
Education
  • On site developmental training for investigators and staff
  • On site facility assessment
Specialty /Therapeutic Areas
  • Allergy/Immunology
  • Anesthesiology
  • Adult and Geriatric Psychiatry
  • Blood Banking
  • Cardiovascular Diseases
  • Child and Adolescent Psychiatry
  • Critical Care Medicine
  • Dermatology
  • Emergency Medicine
  • Endocrinology
  • Family Practice
  • Gastroenterology
  • Geriatric Medicine
  • Gynecological Oncology
  • Hand Surgery
  • Hematology
  • Internal Medicine
  • Maternal & Fetal Medicine
  • Medical Oncology
  • Nephrology
  • Neurology
  • Neurological Surgery
  • Nuclear Medicine
  • Nuclear Radiology
  • Obstetrics & Gynecology
  • Ophthalmology
  • Orthopedic Surgery
  • Pediatrics
  • Plastic Surgery
  • Podiatry
  • Pulmonary Disease
  • Reproductive Endocrinology
  • Rheumatology
  • Surgery
  • Thoracic Surgery
  • Urology
  • Vascular Surgery

 

We invite you to inquire about our Swift enrol program This expedited Investigator recruitment program is implemented to assist Sponsors and CRO's when immediate identification and initiation of a site must occur. We have developed a special network of Investigators who are willing and able to function as emergency, replacement, add on or rescue sites, and will commit to participate in a study within 24 hours of being presented with a protocol and a budget.

Swift enrolform

Should you wish to utilize this service, please download the above form and fax to us at 824 4255925. We will contact you immediately upon receipt to discuss your protocol. Thank you.

Our Associates:

A J Hospital & Research centre
Athena Hospital
Arogya Polyclinic
City Hospital Research and Diagnostic Centre
Colaco Hospital
Dr M V Shetty Memorial Trust
Highland Hospital research and Diagnostic Centre
Indira Hospital
Mangala Hospital & Mangala Kidney Foundation
Mangalore Heart Scan foundation
Mallikatta Neuro Centre
Omega hospital
Prathiba Eye and Vision Care centre
Spandana Hospital, Karkala
Sanjeevini Polyclinic
Unity Health Complex

 

Contact Us:

Dr. Nitin Sashidharan,
Chief Executive Officer and Managing director
Mangalore Clinical Research Foundation,
C-11, I floor,
All-Rahaba Plaza,
Neat State Bank of India,
Nellikai Road, Mangalore- 575001

Email : drnithins@hotmail.com

webmail
drnithin@mangaloreclinicalresearch.in
lakshanakeshav@mangaloreclinicalresearch.in
vaishalirai@mangaloreclinicalresearch.in

 

Location address:Mangalore Clinical Research Foundation
            C-11, Ist Floor,
            All-Rahaba Plaza,
            Neat State Bank of India,
            Nellikai Road, Mangalore- 575001

Proposed Building of MCRF

:Proposed Building

 

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