ASSAY not only provides end to end clinical trial management services, offer a unique platform for clients to experience technology in clinical trials at its best. This brochure provides you an insight on how ASSAY can transform the art of clinical trial management with its agile resources, robust infrastructure and the power of innovation.

1. EXPERTISE
SIMPLIFIED
& TECHNOLOGY

2. ASSAY not only provides end to end
clinical trial management services,
offer a unique platform for clients to
experience technology in clinical
trials at its best.
This brochure provides you an insight
on how ASSAY can transform the art
of clinical trial management with its
agile resources, robust infrastructure
and the power of innovation.

3. ASSAY
About
ASSAY was started in 2012 by a group of like-minded
clinical research professionals to provide project and
clinical trial management services. Today, we have a
team of highly experienced personnel on stand-by to
support your clinical trial needs.
Based in the UK, our operations extend to Europe,
Asia and West Africa. We are also aligned to work
seamlessly with preferred partners to deliver
operations in most other regions across the globe.
We can offer a blend of proven and innovative
approaches to deliver clinical trials on time and to
budget. We combine our expertise with intuitive
technology platforms developed in-house, to run
projects cost-effectively and to fit-for-purpose quality
standards. Our established presence in Sierra Leone
includes a joint training initiative to run clinical trials,
throughout the West Africa region. We can offer
integrated electronic site and central filing system,
e-feasibility, resourcing packages, e-training….. ...
please read on to discover more about our
capabilities ……..
There is something extremely
optimistic about a fresh start.

4. SERVICES
Our
CLINICAL TRIAL MANAGEMENT
TECHNOLOGY
STRATERGIC RESOURCING
ASSAY ACADEMY

5. We can assist you in every phase of your molecule’s
journey. Experience our expertise in a wide range of
therapy areas and our ability to handle challenges
and complications in any clinical trial.
CLINICAL TRIAL
MANAGEMENT
Feasibility Studies
through e-Feasibility
Project/Data/
Safety Management
Training
through
ASSAY Academy
Independent
Quality Assessments
Regulatory
Phase I-IV
studies
Operational
Management
Audit/Inspection
Readiness
Monitoring
Document Management
through GRAVITY

6. It is important that your molecule at every phase of its clinical trial
journey is given the utmost attention and support. Be it any
therapeutic area or a complicated drug, at the end of the day, the
goals are simple. Safety, Efficacy and Quality achieved in minimal
time and cost. With this understanding, ASSAY works with a team
of expert project management and operations teams tailored
specifically for your molecule to provide the best consultation and
service in managing the trial.
Feasibility is a vital part of a clinical trial as the right selection of
potential investigators and sites leads to the successful conduct
of the trial generating quality data. 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 enables you to create study specific questionnaires
to share with potential investigators and track the progress of
completion. With robust reports, project management teams will
find e-Feasibility the perfect solution to recruit potential
investigators to the study in no time. And to top it all, it is
ELECTRONIC completing the process in few clicks.
Feasibility Studies through e-Feasibility
Phase I-IV studies
Management is bringing the right people and right ideas together
at the right time inorder to transform thoughts to action and
output. Our team of expert managers and their associates bring
the best management practices for quality outcome and
efficiency. With a proven track record, be it project management,
data management or safety management, our dedicated team will
handle and deliver every task within the stipulated timeframe
thereby achieving every project milestone.
The secret of success isbeing ready
for the future. At ASSAY, we help you
prepare for an audit or inspection
and provide expert recommendations
on CAPA’s. Within ASSAY, our robust
and advanced systems ensure that
our trials are always audit /
inspection ready at any given time.
Project/Data/Safety Management
We all have come this far, but we have not come alone. There has
always been someone to assist in small to major ways. Our
operational team are here to support the project management
team, ensuring their work-life balance is achieved which
contributes to higher quality project output.
Operational Management
Audit/Inspection
Readiness

7. The clinical research environment can be challenging and
eventually supress the energies of even the most dedicated
workers. Training energises ones hidden abilities and when the
process of training and tracking is simplified, the results are
sucessful. ASSAY Academy is our unique single window training
management system for project and site teams to train and track
project specific requirements with ease.
Training through ASSAY Academy
Quality is key, however in challenging situations, a fresh pair of
eyes and helping hands can enhance the level of quality in a trial.
ASSAY employs task specific experts to review and recommend
CAPA for improved quality.
Independent Quality Assessments
In clinical research, being organised can be challenging. This is
particularly applicable for document management of a clinical trial.
GRAVITY is your long-term solution for site file and trial master file
management. We have integrated the two for logical and convenient
management.
Document Management through GRAVITY
We do not just do monitoring. At ASSAY, we do Efficient monitoring. Our
monitoring services include, routine monitoring, risk-based monitoring,
remote monitoring and project tailored monitoring. We provide our
monitors with the necessary tools and training to effectively utilize
on-site time and prioritize activities. The ASSAY project team will
closely monitor the outcome of each activity and perform trend analysis
to tackle and resolve issues in the shortest timeframes.
Monitoring
Our services are not complete without our expert regulatory consultation
and processing. Every clinical trial conducted by ASSAY is duly submitted to
the regulatory authorities and ethics committees, as applicable, for
approvals. We are also able to submit your drug information for marketing
licenses. Name the country and we will ensure that your clinical trial or drug
is successfully submitted and approved.
Regulatory

8. The world is surrounded by a variety of
technological solutions for every activity
occurring on this earth. Clinical Research is
no alien to technology. But the need for
advancement continues to exist.
Sometimes, the best discoveries
are the result of simple
observations.
ASSAY with its technical team of experts in
clinical research and information
technology together have identified
significant challenges in clinical trial
management at various levels.ASSAY has
developed unique software solutions to
overcome the day-to-day struggles
facedduring the life of a clinical trial.
Any data out of a clinical trial will be suitable for analysis
only when it is organised and preserved appropriately.
However if the process of organising data itself becomes
tedious, the purpose is lost.
ASSAY over though many years of experience, has noted
that filing system for documents generated at various levels
within a clinical trial is often not given due priority because
of the overwhelming volume of patient data generated for
review. However, in an audit, of all the other findings
related to source documents, a vast majority of findings
(major or minor) still lie within the site files and central files.
And to top it all, the time and cost involved in creating,
maintaining and implementing CAPA in the filing sector has
continues to rise as a proportion of costs.
ASSAY has developed a software system to collectively
overcome the challenges of document management in
Clinical Trials and to keep all documents in one place, as
GRAVITY does.
TECHNOLOGY
GRAVITY
Integrated
FOR EASE OF
DOCUMENT SHARING
GRAVITY has changed
the paper-based
Investigator Site File to
Electronic (eISF) and
integrated it with
Electronic Trial Master
File (eTMF) to enable
document sharing.
In-built SUSAR
management system.
Be sure that the most
updated documents
are always available to
all users.
Unique
USER-FRIENDLY
DESIGN
Patient specific logs
like Patient screening
log, Patient enrolment
and consent log, study
specific forms, IMP
Inventory and
accountability logs and
many more have
become electronic.
Is'nt that Unique!!
Robust desigining of
our system creates a
user friendly
enviroment for the
maintanence of
documents.
CRA verification
functionality enables
real-time review of
documents available
at site-level.
Electronic signature
feature enables users
to acknowedge
documents in a few
simple steps.
Logical
FILING AND REPORTING
STRUCTURE
GRAVITY has been
created based on the
DIA eTMF reference
model, keeping in-line
with industry
standards and
expectations, making
it most logical for
document filing.
Generate exclusive
reports for trend
analysis.

9. Secure
DOCUMENT STORAGE
FOR LONG TERM
Cloud security systems
provide controlled
access and cyber
security
Periodic survelliance
and auditing of our
systems ensure that
the information is
contained.
Perfect for post-study
archival
Supported
24/7 BY
OUR EXPERT
HELPDESK TEAM
GRAVITY is backed-up
by our support team
24/7 via phone or
email for training or for
resolving issues.
Accessible
ANYWHERE,
ANYTIME
Like Gravity, our
software is available
for you, whenever you
need it.

10. Site selection is a crucial process for any clinical trial as our decisions
impact the entire execution of the clinical trial. It is important that this
process is handled with care and completed with efficiency within the
stipulated time and cost. E-feasibility is the solution to achieve this.
E-feasibility
ELECTRONIC FEASIBBILITY
QUESTIONNAIRE CREATION
ONLINE FEASIBILITY
SHARING AND MANAGEMENT
DETAILED REPORTING
SYSTEM FOR ANALYSIS
Create your study specific
questionnaires along with
the already available
standard questions
created for you
Send questionnaires to
potential sites and
oversee progress of
completion
Download detailed
feasibility reports and
charts for analysis

11. The world is in your hands all the time. So should your clinical
trial. We at ASSAY bring you this unique platform for creating
mobile applications for your clinical trials to be used by patients
or study teams.
The apps are created specific to your requirements and
deployed and maintained by us. Bring us your ideas and we will
create the best suited apps for you.
Check out our CliniCAL app developed in android platform
which is a tool for calculating a variety of parameters used in
clinical trials.
ASSAY APPS
Success is where preparation and opportunity meet.

12. For the best experience for your trial, require a team of talented,
trained and experienced individuals, Trial management requires
experts to assist you to progress your trial whilst maintaining quality
standards. Our unique staffing solutions through V-Share will ensure
that your requirements are met.
STRATERGIC
RESOURCING
FLEXIBLE
STAFFING
PROJECT-CENTRIC
RESOURCES
LINE
MANAGEMENT
Full-time/
Part-time
Project specific
Experience
End-to-End
Employee
management
Project specific
skills
Training
management
Permanent /
Contractual
INDIVIDUAL
OR TEAM
EXPERIENCED NO RESTRICTIONS
Individual for
a specific task
Specific
Therapeutic
Experience
Irrespective of
size of task
A wide range of
therapy areas to
choose
Not time-boundTeam for an
entire project

13. Investment in knowledge
pays the best interest.

14. The gift of knowledge shared in good faith benefits the giver and the
receiver. A streamlined process paves the way to a quality outcome.
ASSAY
ACADEMY
CLEAR AND STRUCTURED
TRAINING COURSES
SINGLE WINDOW
TRAINING MANAGEMENT
SITE AND PROJECT
SPECIFIC TRAINING
SOP WRITING AND
MANAGEMENT
Tailored basic and
advanced training
courses for beginners.
An opportunity to
refresh for the
experienced
Manage training at all
levels - Site Level, CRA
level, Project
Management level.
Robust reporting and
trend analysis
Develop site and/or
project specific training
materials with ease
Share and track
training material
distribution at various
levels.
Extensive reporting
system for tracking
Expert team for SOP
writing and re-writing
Consultation on
improvement of SOP
to industry standards

15. GLOBAL
REACH
Direct Operations
Europe, USA, West Africa & Asia
Partners
Latin America, Australia.

16. www.assaycr.com
UNITED KINGDOM
56 Pennington Orton Goldhay
Peterborough PE2 5RB
United Kingdom.
INDIA
23, Sheerin Castle,
2nd Main Road, Alwarthirunagar Annexe,
Alwarthirunagar, Chennai -600087
SIERRA LEONE
9 Jakema Street, Bo,
South Sierra Leone