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Excel Lifesciences Private Limited

Noida, Uttar Pradesh

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Excel Life Sciences (ELS) is a US-based, India-focused provider of comprehensive clinical trial management services. ELS is built around passionate and experienced individuals working alongside our clients to accelerate clinical research and delivery of new drugs and medical devices to the markets, while maintaining high standards of quality. We are also committed to improving and expanding the clinical research enterprise, evident through our presentations at industry conferences, publishing in industry trade magazines and journals and through visiting professorship at academic institutions. Here are some basic facts about ELS: US based Delaware Corporation with a fully owned Indian subsidiary focused exclusively on clinical research Over 22 operational locations across India and US offices in Chicago and Boston Clinical operations team is one of the most experienced and respected in India with over 280 years of collective experience Team has conducted more than 350 global and domestic trials at hundreds of sites and with thousands of patients Trained over 1,500 clinical research personnel in India Executive team has spoken at an estimated 175 conferences and has been published over 50 times in industry trade journals and magazines Management team brings experience from some of the most respected and recognized companies within the clinical trials industry and the world, including: Sandoz, Upjohn, Thomson Corporation, CenterWatch, Quintiles, PPD, Unilever, D. Anderson & Company, Microsoft, American Express and Marriott Intl Our extensive domain knowledge helps us understand the expectations and needs of biopharmaceutical and device companies in the US and Europe. Our India operations team and our strategic partners internationally ensure the most cost effective and efficient execution of global drug and device development programs.+ Read More

Nature of Business

Service Provider

Legal Status of Firm

Limited Company (Ltd./Pvt.Ltd.)

Annual Turnover

Rs. 10 - 25 Crore

GST Number

09AABCE5331J1ZO

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Consulting

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Whether it’s needing information and advice regarding the regulatory landscape and operating environment in India, identifying partners for manufacturing, formulation development, licensing, or establishing new operations, Excel Life Sciences has the expertise and track-record to help you do it successfully. Our Clinical Trial & Pharmaceutical Consulting services are designed to mould and adjust to your specific needs, while maintaining a focus on practical solutions and cost effectiveness. Built around the expertise of our personnel who offer over 280 years of collective experience, we can help you successfully navigate the dynamic and challenging clinical research environment in India.

Specifically, ELS offers the following customized consulting solutions:

    Understanding & navigating the regulatory and operating landscape
    Identifying pharmaceutical and clinical research-related partners
    Designing and developing SOPs
    Establishing in-country operations
    Licensing
    Technology transfer
    Formulation development (pilot plant scale and commercial scale)
    Customized Solutions based on your needs

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Cardiology

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Over 30 million adults suffer from Cardiovascular Disease in India. Due to changes in lifestyle and recent economic development, the prevalence of risk factors for coronary heart disease has rapidly increased. The overall incidence of heart disease has doubled in India during the last 20 years and this trend is expected to continue. The World Health Organization (WHO) estimates that 60% of the worlds cardiac patients will be Indian by 2010.

Our statistics show that between the years 2003 and 2006, top sites in India saw over 1,00,000 patients. Some of the most common cardiac diseases seen in this area in India are hypertension, coronary artery disease, arrhythmias and congenital heart disease. The number of Coronary interventions in India is increasing by 25% every year. In 2005, there were over 42,000 angioplasty and nearly 70,000 stent implants.

Our access to the most prominent Cardiology sites and Investigators ensures a large and diverse patient pool and leading lines of medical treatment. Historically, access to such a large group of patients from some of the countries leading cardiology researchers has resulted in achieving enrollment targets on time or ahead of schedule - Though, speed is never a substitute for our focus on quality and ethics. We ensure that clinical trials are conducted according to ICH - GCP guidelines and meet the highest standards of ethics and integrity.

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GCP Training

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Given the dynamic nature of the clinical research industry, training for both new and experienced clinical research professionals is a critical component of any drug development program. This is especially important in India because of the relatively young age of the industry. Excel Life Sciences believes strongly in ongoing training and education, both internally, with our own team of clinical research professionals, and externally with our clients and partners. Our team of instructors has industry leading hands-on clinical trials experience and has trained over 1,500 clinical research professionals, including physicians, executives, CRCs, CRAs and nearly all other stakeholders in the clinical research process. In addition, our instructors are frequent visiting professors at some of India’s top academic institutions for clinical research. Whether it’s at our state-of-the-art training facility in New Delhi, in a hotel conference room or at your offices, we can adapt our programs to meet the needs of groups large and small.

All ELS team members assigned to a project are trained and well versed in ICH GCP and other Indian and global regulatory guidelines. Each operations team members is trained at regular intervals during the course of the trial.

ELS team also imparts ICH GCP and other regulatory to all stakeholders. ELS has trained more than 3,000 research professionals

    Investigators and site team
    Ethics Committee members
    Clinical Research Coordinators
    Clinical Research Associates
    Central Lab team
    Other stakeholders

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Site Management Services

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Site Management Services from Excel Life Sciences help take the burden off of investigators so that they can focus on the patient, and ensure that the study is conducted at the highest standards of quality, ethics and performance. This support ensures collection of high quality study data necessary for regulatory and product approval submissions.

Our proven comprehensive site support model involves placing a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-to-day study conduct activities. The coordinators at our site management organization are trained to provide professional assistance to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of mandated tasks. Supported by an experienced project management team, the study coordinator can have a significant impact on the quality, ethics and performance of the site.

Clean, high-quality data is one of the most critical elements of any clinical trial. Therefore, site management is a core service of Excel Life Sciences and a critical part of our overall customer value proposition. Between the full-time dedicated clinical research coordinator we place at the site and our highly skilled project and site management personnel; we ensure that the data coming out of the investigative sites for your study is the highest quality possible. We have the experience, bandwidth and technology necessary for on-time database lock for any study that we take on and the commitment to make it happen.

ELS offers the following site management services:

Pre-Trial     During the Trial     Post-Trial

    Identify sites
    Identify PIs
    Identify and coordinate translations of Essential documents
    Identify Couriers and other support service vendors
    Regulatory submission & approval with rapid turn-around time
    Obtain import/export licenses for CTM & Samples
    IRB submission & approval with rapid turn-around time
    Site set up
    Document collection
    Create source document template
    Prepare site for SIV
    Pre-screening, in case of chronic disease trials

   

    Assist in the ICF process, screening & enrollment
    Coordinate subject follow up visits preventing lost to follow up & missed visits
    Manage CTM accountability, distribution & logistics
    Coordinate Central Lab logistics & sample flow
    Coordinate Monitoring & Audit visits
    Subject reimbursements
    Maintain and update Trial Master File
    Coordinate SAE reporting on time

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Endocrinology

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An estimated 108 million people in India suffer from endocrine and metabolic disorders. Diabetes is the most prevalent disease in this therapeutic area with approximately 35.5 million cases. It is estimated that by 2030 there will be approximately 80 million cases of Diabetes in India, which is almost twice as many as China which is projected to have approximately 43 million cases. Other common diseases and disorders seen are thyroid, reproductive/infertility, obesity, lipid disorders and growth disorders.

Our clinical investigators have experience conducting global trials and have access to a large and diverse treatment naive patient pool. In fact, these investigators see 400 - 500 new cases per month and provide treatment for approximately 2,000 ongoing cases per month. Some of their fields of expertise are diabetes, thyroid disorder, obesity and lipid disorders. Their research has been published in some of the countries top medical journals including the National Medical Journal of India, Post Graduate Medical Journal and Journal of Association of Physicians of India (JAPI).

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Gastroenterology

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Excel Life Sciences (ELS) has developed one of the most experienced and sophisticated networks of gastroenterology investigators and investigative sites in India. These sites have state of the art facilities, equipment, diagnostic tests and therapeutic procedures available for patients with GI disorders, including: acid-related tests, endoscopy, laparoscopy, manometry, nuclear scans, x-ray contrast studies, nasogastric or intestinal intubation, anoscopy and sigmoidoscopy, abdominal paracentesis, electrogastrography, and electrical impedance testing. CT, MRI, and ultrasound are also commonly performed for GI disorders, and sometimes angiography is used.

Diseases of the digestive system affecting the esophagus, stomach, intestines, liver and pancreas constitute a major problem in India. Anecdotal data suggests that every other person in India suffers with some form of digestive disorder. The less privileged classes, constituting almost 85 percent of the total population, are easy victims to these disorders. Common diseases seen under gastroenterology are Hepatitis and Cirrhosis of the Liver, Chronic pancreatitis, Chronic cholecystitis, cholelithiasis and pancreatitis.

Our researchers have experience conducting global trials and have deep access to a diverse treatment naive patient pool, with each seeing more than 100 new patients every month. Some of their fields of expertise are hepatitis, acid peptic disorders and ulcerative colitis. Their research has been published in medical journals worldwide and throughout India including the Indian Journal of Gastroenterology. Using sophisticated databases of detailed site information, demographics and epidemiology data we can quickly determine if India is the right fit for your study. In addition, ELS can quickly mobilize a team of experienced project managers to conduct a study feasibility analysis and determine the appropriate sites and availability of patients. Contact our business development team today to learn more!

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Excel Life Sciences (ELS) has significant experience in running and supporting clinical trials for HIV and infectious diseases in India. In fact, ELS has one of the largest networks of investigative sites and investigators in India, including some of the countries leading investigators and centers treating infectious diseases. India's socioeconomic status, traditional social norms, cultural myths on sex and sexuality, large-scale migration and a huge population of marginalized people make it extremely vulnerable to the AIDS epidemic. A report released at the 16th International AIDS Conference in 2006 says that even though India has made considerable progress in slowing the spread of AIDS, it still has between 5.5 and 6 million HIV-positive individuals accounting for nearly 60 percent of Asia’s 10 million infected. Many patients are treatment naïve and non-transient. These factors typically result in shortened enrollment times.

Investigative sites within the ELS network have the experience and infrastructure necessary to conduct global clinical trials requiring the highest levels of ethics, quality and performance. They have deep access to a diverse treatment naive patient pool, with each seeing more than 100 new patients every month. Their fields of expertise include the following anti retroviral treatments - NRTI + NNRTI and NRTI + PI. Many have been published in international medical journals and Indian journals including the Journal of Acquired Immune Deficiency Syndrome.

Using sophisticated databases of detailed site information, demographics and epidemiology data we can quickly determine if India is the right fit for your study. In addition, ELS can quickly mobilize a team of experienced project managers to conduct a study feasibility analysis and determine the appropriate sites and availability of patients. We have significant experience in the area of infectious disease and we are confident that we can assist you with your next study. Contact our business development team today to learn more!

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As the number of clinical trials conducted in India continues to increase at a rapid pace, so does the need for qualified investigators and site staff to conduct those studies. While India has one of the worlds largest and most experienced physician populations with over 600,000 physicians across the country, the number of clinical research-experienced and GCP-trained clinical investigators are still low. Also, these physicians typically have very large daily patient loads and lack the free time to run a clinical study effectively without assistance. Compounding the issue even further, ELS research has found that less than 10% of all investigative sites in India have a full time clinical research coordinator on staff.
Site Management Services from Excel Life Sciences help take the burden off of investigators so that they can focus on the patient, and ensure that the study is conducted at the highest standards of quality, ethics and performance. This support ensures collection of high quality study data necessary for regulatory and product approval submissions.

Our proven comprehensive site support model involves placing a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-to-day study conduct activities. The coordinators at our site managment organization are trained to provide professional assistance to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of mandated tasks. Supported by an experienced project management team, the study coordinator can have a significant impact on the quality, ethics and performance of the site.

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