Clinical Trials

We specialise in overseeing clinical research sites. Having 400+ hospitals as part of our current client portfolio, we aspire to become India’s fastest growing SMO ( Site Management Organization ) 

Advantages for hospitals to start clinical trials

Clinical trial researchers are crucial to the creation of medicines that treat chronic and degenerative illnesses, fight disease, and advance global health.

The number of clinical studies necessary to thoroughly analyze the numerous novel medications, treatments, and technology now being developed has significantly increased.
These clinical trials require investigator participation from physicians in private practice. Clinical trials offer doctors a number of benefits, including:
Professional advancement – Stay on the cutting edge of your particular therapeutic area of interest, network with other clinical trial investigators to share ideas and arrange future collaborations, and develop comfort working with medications and procedures that the U.S. Food and Drug Administration has not yet approved (FDA).
Professional Acceptance– Clinical trial investigators may have the chance to co-author articles for publication because they are frequently seen as thought leaders in the profession.
Financial growth – There is potential for increased income from clinical trials.
Function in the development of medicine– Researchers working on clinical trials may introduce ground-breaking goods to the market that have a global health impact.

Contract research organisations (CROs), pharmaceutical firms, biotechnology businesses, medical device companies, and even clinical research sites use our SMO services

We specialise in overseeing clinical research facilities. We have a network of clinical research sites that we oversee and collaborate with regularly… based on the understanding and agreement with the head of the clinical research site, which could be a hospital or a private practice, we manage all or part of clinical research activity at a clinical research site.

Why you should not start clinical trials on your own, and Need SMO ?

“SMOs aims to provide cost-effective clinical trial conduct and specializes in running clinical research sites effectively” – Ankit Sakhreliya, clinical trial expert

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Benefits of working with an SMO

Clinical research teams can get various advantages from working with a site management company, including:

Faster patient recruitment – Compared to internal teams, SMOs are more effective in attracting and keeping patients by utilizing networks of qualified patient pools and quick follow-up.

Improved data management – SMOs decrease delays that can occasionally occur with study and regulatory data addressing inefficiencies because they have the technology infrastructure and data handling mechanisms in place to manage both clinical and regulatory data.
Focussed Research: Improved research team focus Spending more time cleaning data than interpreting data is a common mistake clinical research teams do. Research teams have more time to study important data because the menial labour is delegated to SMOs.

Shorter study timeframe and cost-effective: SMOs offer end-to-end clinical trial-related services, from setup to monitoring, compliance activities, and closeout, to speed up clinical research timelines and stay under budget. This results in shorter study timeframes and cheaper expenses.

Therapeutic Areas

We work in following therapeutic areas : 

  • Cardiology
  • Oncology
  • Dermatology
  • Pediatric
  • Autoimmune Diseases
  • Gastrology
  • Respiratory
  • Urology
  • Rheumatology
  • Orthopedics
  • Psychiatry
  • Gynecology
  • Ophthalmology
  • Metabolism & Endocrinology
  • Nephrology
  • Neurology
  • Infectious Disease
  • Rare Diseases
 

Role and Responsibility of Clinical Trial Site:

Conduct the clinical trial in accordance with the relevant regulations and GCPs, which includes:

  • Implementing systems and procedures for the monitoring and assessment of safety in CTs
  • Obtaining REB approval and notifying the sponsor of that approval
  • Ensuring that the staff conducting the trial has the necessary training and experience
  • Ensuring that the trial’s goals, procedures and tests involved, potential risks, and anticipated benefits are all clearly stated.
  • Give assistance to study participants, including the name and phone number of the researcher and the head of the research ethics board.
  • Offer trial subjects’ medical treatment linked to the trial
  • Express concerns to the sponsor as soon as possible –
  • Support the work of the sponsor, inspectors, and REB –
  • Inform the REB, sponsor, and regulator of any significant or unexpected ADRs
  • Respect the trial’s design, including randomization and blinding, and adhere to the protocol as specified.
  • Label, utilize, and store the medication in accordance with the laws, the protocol, and the literature provided by the investigator.
  • Keep correct documents, such as source records, REB attestation of acceptance of all protocol versions and informed consent forms, and all original signed informed consent forms for every subject for all protocol versions, if necessary.

Services we provide :

Study staff training
Site SOP preparation
Site Identification feasibility
IRB/IEC submission
Contract and Budgeting
Subject recruitment
Inform consent process
Patient recruitment
AE/SAE
Case report form
IP management
Monitoring and Audits
Communication with CRO
Business development for site
Study close out

Our Studies :

COPD
Heart Health
Chronic Cough
Diabetes
Eczema
IBS
Memory Loss
Fibromyalgia
Gout
GERD
Renal Sciences And Transimmune
Infectious Disease
Hepatic Sciences
Onco Sciences
Rheumatic Sciences

Our aim is to deliver professional, high-quality clinical research through a committed network of clinical investigative sites with big, easily accessible patient populations.

Why us : 

  • Conformity with GCP, ISO, and local regulatory standards
  • Performance evaluation and continual improvement
  • Extensive quality control processes

We have a well-established Quality Management System. All Medigence operations are carried out in accordance with established Standard Operating Procedures (SOPs) and, where applicable, with local/regional specific procedures. Our SOPs and corporate quality policies assure compliance in all aspects of our business

In addition to these fundamental areas, our unwavering commitment to quality is reflected in the training we give to our personnel. Our reputation for outstanding quality guarantees that all site operations personnel are well educated in both clinical and administrative elements.

 We are convinced that developing and implementing an effective training strategy is critical to the success of service delivery. Medigence site operations workers receive regular operations training to guarantee that their skill set surpasses current regulatory criteria. The training strategy comprises GCP and related regulatory training, SOPs/Work Instructions, and targeted job and study specific training. Our thorough and specific training translates into efficient work delivery on-site.

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We assist with the recruitment of patients in accordance with the study protocol, ensuring that study participants are educated about study procedures, visit dates, and laboratory tests, among other things. We provide you with effective recruiting methods and also help you connect with doctors so you can start and run patient studies successfully.

We will also work with investigators and hospitals as a service provider. Our key tasks at the location are patient identification and recruitment. We will also assist the site with all documentation-related tasks, such as file management.

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We strive to shorten the patient recruitment time and improve patient compliance throughout the trial as a result of excellent follow-up by our employees deployed to clinical research sites. Our plan is to bridge the gap between regional hospitals and investigators, develop strong relationships and realize their study goals.

We wish to create a fully integrated network of field and patient service centers that will help your clinical research.

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Our team :

We have a team of seasoned and certified specialists with clinical study expertise and a grasp of customer demands. Our team has a diverse range of skills from many industries. We have established a standard in offering competent CRO services in the areas of clinical trials, research, and patient recruitment, as well as strong relationships with doctors and the pharmaceutical sector. Our team consists of the following people:

Investigator, Co-investigator, Study coordinator, Nurse Pharmacist, In blinded trials, unblinded personnel (Coordinator/Nurse/Pharmacist)

What is a site management organization ?

A site management organization is a service provider that offers the clinical investigator at a study site operational and administrative support services. This covers everything from managing patient recruitment and data collection to managing regulatory and compliance tasks. SMOs can help with study start-up, monitoring, and close-out as well.
SMOs collaborate with pharmaceutical firms, biotech firms, clinical research facilities, contract research organizations (CROs), and other businesses to help them deliver their research quickly.

What are clinical studies : 

People seldom think about how therapies have come to be available to them, although everything from aspirin to chemotherapy has been thoroughly studied before being given by your doctor.
Medigence specialises in ‘late phase’ clinical trials. 

These studies investigate the effects that the medications being examined have on the illnesses that they were meant to treat, and all will have gone through some earlier phase testing. We have a wide range of research to fit a wide range of treatments and ailments, the findings of which are assisting in ensuring a healthy future.

A clinical trial is a research study in which human volunteers are used to evaluate novel ways of disease screening, prevention, diagnosis, or treatment. A clinical trial is used to see if a new treatment or therapy is both safe and effective. Clinical trials also help to discover new applications for current medications or therapies. To protect the safety of patient participants, clinical studies are carefully developed and supervised. The Food and Drug Administration (FDA) requires clinical studies before any drug may be used by the general population.

Physical exams, laboratory testing, and other medical procedures are used by research coordinators and physicians to closely monitor study participants during the study. These operations are frequently referred to as an extension of what has historically been done to manage the patient’s health and medical condition. Throughout the course of the study, patients in research studies are provided with free study medicines, examinations, and assessments. Patients can save thousands of dollars on prescriptions and clinic visits by participating in studies that might last weeks, months, or even years.

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