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ASSAY Clinical Research

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Peterborough, GB

About ASSAY Clinical Research

ASSAY with its global presence is a service provider of innovative and technologically advanced solutions for clinical trial management for the pharmaceutical, biotechnology and medical device industries. We also extend our services to clinical research organizations who require tailored services for managing... Show more »

ASSAY with its global presence is a service provider of innovative and technologically advanced solutions for clinical trial management for the pharmaceutical, biotechnology and medical device industries. We also extend our services to clinical research organizations who require tailored services for managing their clinical trials. We focus on developing effective strategies for the collection, management and analysis of clinical data. With us, we guarantee that Sponsors, CROs and Sites can gain access to the best services for Phase I-IV clinical studies, study management and site management. We also ensure that the best skills and experiences are put in place to achieve the milestones efficiently. Together we can aim to achieve maximum patient safety and accurate data generation with highest quality and regulatory standards.

Established in the UK in the year 2012, ASSAY Clinical Research started with a group of clinical research professionals who have been providing a variety of services for the pharmaceutical industry and other clinical research organizations. Gradually, ASSAY has gained recognition for its quality, timely services with affordable costs. Our services were quickly extended to European regions and India. With the deadly outbreak of Ebola and the need to test the vaccines, ASSAY was chosen for project management, data management and monitoring services and these services in Sierra Leone.

With growing number of research activities around the globe, it is increasingly essential to keep up with the quality and timelines to save potential lives and curb the budget. With ever changing dimensions of research companies and the demand for therapeutic specific experience, the challenges to find the right resources has suddenly become massive leading to a demand and supply issue. ASSAY is here to help you with this. Our experienced team of project managers, clinical research associates and in-house team will be able to understand your challenges and needs in a time efficient manner and plan out the CAPA for you and implement it at any level which may be considered appropriate (Site Level, CRO level, Sponsor level, Country level, Region level or Global).

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Our Services (20)


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Trial Master File (TMF) Management

Price on request

Gravity an integrated eTMF and eISF.

Gravity an integrated eTMF and eISF.

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Clinical Site Auditing

Price on request

The secret of success is in being ready for what is to come. At ASSAY, we help you in getting ready for an audit or inspection and provide expert recommendations on CAPA. Within ASSAY, our robust and advanced systems ensure that our trials are always audit / inspection ready at any given time.

The secret of success is in being ready for what is to come. At ASSAY, we help you in getting ready for an audit or inspection and provide expert recommendations on CAPA. Within ASSAY, our robust and advanced systems ensure that our trials are always audit / inspection ready at any given time.

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Feasibility Studies

Price on request

Feasibility is a vital part to begin a clinical trial as the right selection of potential investigators and sites leads to a successful conduct of the trial with quality data generation. Our aim is to complete this phase quickly and effortlessly with quality results. At ASSAY, we are always on stand-by to take up a feasibility... Show more »

Feasibility is a vital part to begin a clinical trial as the right selection of potential investigators and sites leads to a successful conduct of the trial with quality data generation. Our aim is to complete this phase quickly and effortlessly with quality results. At ASSAY, we are always on stand-by to take up a feasibility requirement in any region of the globe as we have a strong database of potential investigators/sites in every therapeutic area.
E-Feasibility provides you the ability to create study specific questionnaires and share it with potential investigators and track the progress of completion. With robust reports, project management team will find e-feasibility the perfect solution to recruit potential investigators to the study in no time. And to top it all, it is all ELECTRONIC completing the process in few clicks.

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clinical trials

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Medical Device Clinical Trials

Price on request
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Clinical Data Management

Price on request

Electronic Trial Master file & Investigator site file

GRAVITY is an integrated Electronic Trial Master File (eTMF) and Electronic Site Master File (eSMF) developed with the aim to provide a complete solution to the document management at various levels of a clinical trial team.
GRAVITY is:

A Private Cloud-based... Show more »

Electronic Trial Master file & Investigator site file

GRAVITY is an integrated Electronic Trial Master File (eTMF) and Electronic Site Master File (eSMF) developed with the aim to provide a complete solution to the document management at various levels of a clinical trial team.
GRAVITY is:

A Private Cloud-based System
Compliant with 21 CFR Part 11
Developed based on the TMF Reference Model
Repository and window for documents generated at the trial level and site level
Secure, User-friendly and Unique
A document management system for Sponsors/CROs/Sites
Accessible 24/7, anywhere in the world
Easy to manage and archive
Online study logs
CRA remote ISF verification process
Integrated SUSAR system
electronic signature
QC assistance.
24/7 technical support.
tailor made with client requirements.
Quick and Easy to install and implement

GRAVITY as an eTMF acts as a store-house of all the clinical trial documents generated for the entire duration of the trial. Since developed based on the TMF Reference Model, GRAVITY meets the expectations of the industry standards for a complete eTMF structure. With sections and tabs easy to comprehend and use, GRAVITY ensures that users experience the smooth logical flow of document management every time.

GRAVITY as an eSMF serves as a unique system for sites to manage the Site Master File (or otherwise known as Investigator Site File) in an electronic format without the hassle of a conventional paper based filing system. GRAVITY greatly reduced the need to print and manage the large amounts of clinical trial documents on a daily basis thereby reducing the resources and time involved in this task.

GRAVITY as an Integrated eTMF and eSMF becomes a unique document management system which serves as a window between the Sponsor/CROs and Sites. This system ensures that the eTMF and eSMF are simultaneously updated when a document is generated (based on the criteria involved in sharing the document). It ensures updated documents are shared with various levels of the team in a timely manner, maintaining utmost confidentiality required for the sensitive nature of the documents generated.

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VENTANA Vector Software Data Management clinical data Immunology Oncology Rare Disease CNS/Neurology Aging Cardiovascular Infectious Disease Respiratory Metabolism and Endocrinology Arthritis Melanoma Acute Myeloid Leukemia (AML) Acute Lymphocytic Leukemia (ALL) Fibrosis Cirrhosis Ulcers Atrial fibrillation Breast cancer Chronic obstructive pulmonary disease (COPD) Lung Cancer Alzheimers Disease Asthma HIV Tuberculosis Drug Discovery Antibiotic Development Show 30 more tags Show less

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Clinical Trial Monitoring

Price on request

As soon as a protocol is finalized and ready to be introduced to potential investigators who would facilitate in conducting the trial, the clinical monitoring team gears up to be in the front line between the study site and the sponsors. Their crucial role in maintaining the safety and efficacy of the trial and to maintain ethics... Show more »

As soon as a protocol is finalized and ready to be introduced to potential investigators who would facilitate in conducting the trial, the clinical monitoring team gears up to be in the front line between the study site and the sponsors. Their crucial role in maintaining the safety and efficacy of the trial and to maintain ethics and quality calls for a team of most experienced and trained. ASSAY will assist you through this. At ASSAY, we identify clinical monitors who are experienced in the therapeutic area and are experts in supporting the site staff and in maintain high levels of communication skills. Our extensive training programs for our monitors ensure that we are able to deliver quality performance well within the timelines and costs. Our Clinical Monitoring Services are tailor made to your needs. It can range from: Study plan development , Site and supply management , Regulatory documentation management , AE and SAE management , Source document review , Clinical Operations We will serve as a clean and transparent window which will ensure open communication and lead to the success of the clinical trial in every aspect. We will excel for achieving excellence.

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Infectious Disease Acute Myeloid Leukemia (AML) Acute Lymphocytic Leukemia (ALL) Anemia Alopecia Diabetes Anxiety Inflammatory Bowel Disease Atrial fibrillation Prostate Cancer Breast cancer Chronic obstructive pulmonary disease (COPD) Hepatitis B Alzheimers Disease Cystic fibrosis Ovarian Cancer Johne's disease HIV Arrhythmia Bone disease Tuberculosis Antibiotic Development Show 22 more tags Show less

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Clinical Trial Management

Price on request

For complex global trials or focused regional studies in all phases, the right research partner makes all the difference in how well your trials run. Based on your specific research requirements, ASSAY assigns you an expert project manager and a dedicated team, including researchers experienced in your particular therapeutic area.

For complex global trials or focused regional studies in all phases, the right research partner makes all the difference in how well your trials run. Based on your specific research requirements, ASSAY assigns you an expert project manager and a dedicated team, including researchers experienced in your particular therapeutic area.

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Regulatory Affairs Consulting

Price on request

Clinical Trial set-up is the first and most crucial step towards successfully conducting the trial for the given duration. With stringent regulations in every region and country and its ever changing requirements, it is important to choose the right partner to start off the regulatory submissions which will ensure that all the... Show more »

Clinical Trial set-up is the first and most crucial step towards successfully conducting the trial for the given duration. With stringent regulations in every region and country and its ever changing requirements, it is important to choose the right partner to start off the regulatory submissions which will ensure that all the requirements are taken care off by the right and experienced people. At ASSAY, our team of experienced professionals who are trained and constantly updated with the regulatory requirement of each country, will be able to assist you throughout the submission process for central regulatory agencies, local regulatory authorities (country and site specific) and license management (import and export licenses) throughout the duration of the trial. Our commitment to ethical standards and adherence to regulatory guidelines will ensure that our sponsors receive the correct consultation and assistance in every step of the regulatory submission.

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Phase IV Clinical Trials

Price on request

A safe journey from development to commercialization is vital to make the drug reach out to the humanity. ASSAY with its trusted partners will successfully conduct post marketing studies through our strong therapeutic expertise, good documentation and effective communication. ASSAY will strive to assist our sponsors in the... Show more »

A safe journey from development to commercialization is vital to make the drug reach out to the humanity. ASSAY with its trusted partners will successfully conduct post marketing studies through our strong therapeutic expertise, good documentation and effective communication. ASSAY will strive to assist our sponsors in the post-approval process in a cost effective manner within the expected timelines.

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Phase III Clinical Trials

Price on request

Due to the sheer size and complexity of phase II and III trials in terms of recruitment, duration of the study and the costs involved, it is important that the most experienced and trained resources are available in order to obtain the most accurate results. At ASSAY, we have the ability to get connected to the perfect resources... Show more »

Due to the sheer size and complexity of phase II and III trials in terms of recruitment, duration of the study and the costs involved, it is important that the most experienced and trained resources are available in order to obtain the most accurate results. At ASSAY, we have the ability to get connected to the perfect resources and expertise throughout the globe which will ensure that clients / sponsors are provided customized plans to execute their clinical trials successfully within the timelines and budget and with high quality standards. We offer Clinical monitoring, Data Management, Project Management, Investigator Recruitment and site management, Protocol and CRF designing, Patient Reported Outcome management, Feasibility studies, Interactive technologies and any other customized services as required by the clients or project. ASSAY is committed to patient safety, ethics, quality and paramount client service.

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Phase II Clinical Trials

Price on request

Due to the sheer size and complexity of phase II and III trials in terms of recruitment, duration of the study and the costs involved, it is important that the most experienced and trained resources are available in order to obtain the most accurate results. At ASSAY, we have the ability to get connected to the perfect resources... Show more »

Due to the sheer size and complexity of phase II and III trials in terms of recruitment, duration of the study and the costs involved, it is important that the most experienced and trained resources are available in order to obtain the most accurate results. At ASSAY, we have the ability to get connected to the perfect resources and expertise throughout the globe which will ensure that clients / sponsors are provided customized plans to execute their clinical trials successfully within the timelines and budget and with high quality standards. We offer Clinical monitoring, Data Management, Project Management, Investigator Recruitment and site management, Protocol and CRF designing, Patient Reported Outcome management, Feasibility studies, Interactive technologies and any other customized services as required by the clients or project. ASSAY is committed to patient safety, ethics, quality and paramount client service.

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Phase I Clinical Trials

Price on request

We understand that that a molecule, at the start of its journey, requires the most attention to make it into a potential life saver drug in the future. With our expertise in handling various types of studies, experience in a wide range of therapeutic area, our ability to handle different dosage forms and complicated protocols... Show more »

We understand that that a molecule, at the start of its journey, requires the most attention to make it into a potential life saver drug in the future. With our expertise in handling various types of studies, experience in a wide range of therapeutic area, our ability to handle different dosage forms and complicated protocols enables us to provide innovative and quality solutions to your studies. Our services for phase I trials includes designing and managing of First in man studies, Proof of concept studies, Bioavailability and Bioequivalent studies, Drug interaction studies, Dose escalation studies, safety studies and special population studies. We will be assigning a dedicated team headed by a project manager, all of whom will be experienced in handling your requirements along with the therapeutic knowledge required. The team will be accessible to you anywhere, anytime which will allow establishing good communication, robust planning and minimising risks in the most time and cost efficient manner. After all, patient safety is achieved through protocol compliance and our working model will ensure that this is achieved with highest quality standards including GLP, ICH, GCP and all other local regulatory guidelines. ASSAY with its technologies and expertise will assist you through every step of your trial.

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Clinical Trial Management Systems (CTMS)

Price on request
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Clinical Trial Documentation Support

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Project Management

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Clinical Research

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Clinical Data Collection, Analysis and Management

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Clinical Trials, Consulting, and Management

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Business Development Consulting

Price on request
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Regulatory Affairs Services

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