Skills needed
Because the study coordinator needs to be in constant communication with patients, clinical monitors, doctors and other health workers, strong interpersonal skills and the desire to help people in general are highly recommended. The study coordinator must also have great organizational skills, to be able to manage several studies at once, and be able to adapt to different situations quickly. It is essential for a study research coordinator to have strong computer skills for daily use of emails, text documents, spreadsheets software and much more.

Work Setting
Typically, study coordinators work in clinics, hospitals, education or research centers and other types of health centers.

Work Hours
Normally, study coordinators work regular hours, Monday to Friday. However, in some cases, work hours will depend largely on the type of study conducted. Some studies require more flexibility in time, such as starting work early, finishing late, or even working on the weekend to accommodate the schedule of some patients. Also, there may be some traveling involved with the beginning of every new study.

Education
Depending on the type of studies, facilities, and needs, study research coordinators type of education can vary a lot, from bachelor/master in health science or biology to registered nurse. Because every studies are different, and because they are in constant proximity with subjects and patients, study coordinator should have CPR training. Moreover, it is mandatory for study coordinators to know the principles of Good Clinical Practice, to ensure full protection of the study subjects. Study coordinators can be certified through the ACRP or SoCra, the Society of Clinical Research Associates.

For more information about careers in Clinical Trials, please visit Clinical Trials Info now.

For one million of molecules, only a thousand will be selected for further research, and of them, only one will become a commercialized drug. The cost of development for each marketed drug is estimated to 1 billion dollars. A patent for a new drug is good for 20 years, but also include clinical trials phase I to III. From clinical trial phase I day 1 to the day it is approved by the FDA, Health Canada or other federal organizations and marketed, it usually takes about 10 years. But to those 10 years, another 3 years is needed to pay back the cost of development of the molecule, leaving only 7 years to make this new molecule profitable. With the quick apparition of generic molecules, pharma companies need to keep their price low to remain in the competition. And with today’s competition, this time laps is even shorter. The internationalization of the pharma industry and the merge of more and more phama into giants are also an imminent threat to the profitability of new molecules, therefore the survival of many pharma.

This is why delay and costs in operations will drive in what countries clinical trials will be conducted Delays in operation means a reduce efficiency, leading to million of dollars losses due to missed market opportunities for potential blockbusters. Often, those delays can often be explained by difficulties in recruitment and patient retention.

Once leaders in clinical trials, Europe, U.S., Japan and Canada are now losing quickly to emerging markets such as India, China, Eastern Europe and Brazil. While the number of clinical trials have reduced in Western Europe, U.S. and Canada, there has been a strong increase in the new markets. Recent reports have shown that the number of clinical trials conducted in Eastern Europe has tripled in only 5 years, and that the cost in those countries was easily cut in two.

The “Patient Recruitment and Retention in Clinical Trials” report was released by the Busines Insights.

The report states that:

- as much as 50% of trial delays are caused by lack of patient recruitment, leading to over $500,000 in lost sales and resulting in losses of over $8m for blockbusters.
- there are under utilized tools in the US, Europe and Japan, such as the Internet
- there is a migration from the U.S. and Western Europe to offshore locations that are cheaper. As a matter of fact, leaders, such as GSK, Pfizer, Roche and Norvatis, all have an established presence in India, China and Eastern Europe
- there is an under-investigation effects in women, and in the U.S. and the EU, women are under-represented in clinical trials.

In order to keep clinical trials to come back, industrialized countries need to increase patient recruitment and retention in order to compete with the emergent makets.

For more information, visit Clinical Trials.

With its 140 characters maximum messages, Twitter is a good example of a social media website that can be used towards reaching this target.

For example, @crgonzalez’s article “Whispering Tweets into a Patient’s Ear: Top Ten Suggestions for Clinical Trial Recruiters” suggests great ways to use twitter and its add-ons to optimize recruitment in clinical trials.

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In summary, Gonzalez’s article suggests

• To include and validate through an ethics committee board the use of a Twitter account as a strategy to recruit subjects in clinical trials

• Twitter will be used to help circulate information about current studies and where to look for further information (websites, phone numbers, etc), which information would also be approved by an ethics committee

• To optimize the Twitter message by using relevant hashtags (a way to unite global Tweets around some particular topic )

• To follow the impact generated by the message using one of the many available add-ons and apps such as tweetscan

• To apply netiquette Twitter rules, which are to be spontaneous, to be clear, to be concise, to bring the relevent information in order to allow retweets and get others to talk about it

Another great example of Twitter application is presented by trialx.org in their article, “Now You Can Talk to Twitter and Find Clinical Trials on TrialX“. Trialx.org is a website that connects patients and study investigators.

Trialx has created their own Twitter account that allows anyone looking for a study to send a tweet starting with CT (for clinical trial), followed by a short presentation (age,sexe,disease/pathology). A personnalized answer is sent by @trialx to that person. That personnalized answer includes relevant studies trialx.org is aware of. @trialx can also, confidentially, communicate directly to the potential subject.

For more information, visit Clinical Trials.

info@perceptive.com

Perceptive Informatics, Inc., the industry’s leading eClinical solutions provider, combines clinical knowledge, quality and regulatory experience with advanced technology to decrease time to market, risk and cost associated with clinical trials. Perceptive’s comprehensive eClinical technologies and services optimize the product development and commercialization process for pharmaceutical, biotechnology, medical device companies and associated service providers.

MEDICAL IMAGING
Perceptive’s Medical Imaging Group offers consulting for imaging-based trials, image collection, independent image analysis and review, and regulatory submission. Our experts use leading imaging technologies, and cover a wide range of therapeutic areas such as Oncology, Musculoskeletal, Cardiovascular and Central Nervous System (CNS) imaging. Perceptive is successfully using MR, CT, and PET scans, x-ray, DXA, ultrasound and digital photography and other advanced imaging modalities as surrogate endpoints.

INTERACTIVE VOICE/WEB RESPONSE SYSTEMS (IVRS & IWRS)
Perceptive’s ClinPhone® IVRS/IWRS provides sophisticated voice and web systems to effectively collect data, screen and randomize patients, and manage study drug inventory. These solutions are powered by proven and fully-validated technologies and supported by robust system infrastructure. A 24-hour multilingual help desk is equipped to respond to questions relating to all aspects of the ClinPhone IVRS/IWRS.

ELECTRONIC DATA CAPTURE (EDC)
The DataLabs® Electronic Data Capture (EDC) solution from Perceptive enables clinical study sponsors and their service providers to streamline the clinical data management process and improve the efficiency and data quality of clinical studies. The DataLabs system incorporates the advantages and flexibility of hybrid technology, unifying paper data entry and EDC into a single clinical data management platform.

CLINICAL TRIAL MANAGEMENT SYSTEMS (CTMS)
Perceptive’s IMPACT® solution provides the top global pharmaceutical companies a flexible solution with feature breadth and depth.

The TrialWorks® CTMS from Perceptive is well-suited to emerging biopharmaceutical companies that demand rapid implementation and low total cost of ownership.

ELECTRONIC PATIENT REPORTED OUTCOMES (ePRO)
Perceptive’s industry-leading ePRO solutions encompass best-of-breed offerings and consulting for the two most commonly used solutions – device-based and IVR.

INTEGRATION SERVICES
Systems integration enables a seamless connection between systems, giving clinical development teams access to the critical data and information they need to make earlier, better trial management decisions. Perceptive’s team has expertise in the technologies used in the clinical enterprise, data formats and exchange, and data interchange standards. Services include integration of Perceptive products within a sponsor’s environment with other software assets, and delivery of proprietary web-based tools.

Perceptive Informatics is the technology division of PAREXEL International, a leading global biopharmaceutical services provider with 69 locations throughout 52 countries.

Contact:

Perceptive Informatics®, Inc.
200 West Street
Waltham, MA 02451
U.S.A.
T: +1 866 289 4464
F: +1 781-768-5512
Email: info@perceptive.com
Web: www.perceptive.com

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Be up-to-date with important drug discoveries by attending the 2009 conference! You will learn about the latest trends in drug discoveries and development. Because of key products suffering patent expiration in the upcoming years, pharmaceutical and biotech companies are pressured to resolve drug discovery bottlenecks and produce drugs that are more innovative, with a higher efficacy yield and overall safer. The economic turndown is taking its toll across the country, and this year conference will give you the insights and solutions at a cost that will not prevent you from attending – sign up now, it’s free.

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http://www.opalevents.org

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Yes, there are jobs in the clinical research and other connected industries. This is what pharmaceutical companies are confirming. Despite the past months turmoils in the world’s global economy, jobs are still offered in the clinical research industry recession and has yet to affect those working in the industry. Student are still welcomed to apply for paid internships, and are likely to get jobs.

Darcy Johnson, a clinical research monitor based in the U.S. and Linna Lui, a clinical trial coordinator in Canada both mention that they did not notice any slowdown in the clinical trials industry. Clinic sites are still been approched for clinical trials. Many pharma companies are in good economic health. Of course, there are fewer raises and promotions. Even if the money is there, companies are more careful, because they don’t know how everybody will cope with the economic turndown on the long run.

The merge between Wyeth and Pfizer has worried more than one about the future of the pharma industry

The recent merge between big pharma, such as Wyeth and Pfizer had led to several lay offs and worries among many others. However, this type of merge happens in all industries, and lay offs are unavoidable as a duplicate of the workforce is created by the merge.

Although there have been cuts in the pharmaceutical companies, most costs occurred at the base of drug discovery, and is not affecting the later stage of drug development.

Computerizing clinical trials can help managing your business in a click. By using a computer software, you will be able to manage the bulk of your work and projects from a single computer, and cut down the number of endless meetings between project managers and investigators. Hence, clinical trial software will simplify clinical research, making them less expensive to run. Clinical trials software are expertly developed to give solutions to people like you, who need an easy and resilient way to maximize research funds.

Because they can be run online, clinical trial software are a must for people who need to transit a lot, so they can manage and work away from the office. Using a clinical trial management software will allow you to keep up-to-date with the latest events or changes throughout the study. Also, by computerizing will allow you and relevant people to have access to more succinct and relevant information in a timely manner, preventing discrepancies. Hence, when necessary, quick decisions can be taken quickly, avoiding unnecessary loss of time. Computer software can be used in various ways, find out how it can help your organization or business run in a more efficient way.

When choosing a software for clinical trials, make sure you are choosing the right program.

1.Your software should be adequate for the size of your organization (small, medium, large)

2.It should adhere to ICH regulations, as well as your country regulations about clinical trials

3.Preferably, your software should be have the flexibility to add other regulations in the system, such as your organization’s, province or state

4.Your clinical trial software should be user friendly, therefore easy to learn and use

5.Your software should be able to be upgraded easily, providing that important change are made in the ICH regulations, or other relevant ones

6.The provider should offer a good support, even if you have a good IT team

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7.Some providers offer on-demand clinic trial software: you can get the whole package, or cut down on the price and take only what is important to you

8.Many providers offer you a free demo. It would be a good idea for you (and your coworkers) to try out their system before transferring your whole clinical trial to their software

9.Some companies offer open source software, so you can adapt their software to your needs

10.Finally, ask for other people’s opinion (key employees). By having important staff participate in the final decision, you will increase your chances to make the right software choice.

OpenClinica is an example of an open source clinical trial software, and offer the flexibility of adding or making changes to your software accordingly to your needs

]]> http://www.clinical-trials-info.com/picking-clinical-trial-software/feed/ 0 http://www.clinical-trials-info.com/joining-a-clinical-trial-in-4-steps/ http://www.clinical-trials-info.com/joining-a-clinical-trial-in-4-steps/#comments Fri, 27 Mar 2009 21:23:28 +0000 Clinical-trials-info author http://www.clinical-trials-info.com/?p=654 4 steps to joining a clinical trial

How to become a clinical trial volunteer

Because of what it implies, few people are willing to become a clinical trial volunteer. It is known that, by joining a clinical trial, you expose yourself to possible risks or side effects. Clinical trials are the last step of drug development (sometimes also health devices), and are required before any new drug can be release onto the market. New drugs can be released only if they are proven to be safe for the population and if they show a good efficacy for the targeted disease. Safety data of a new medication on animals is insufficient for its approval by the FDA or other health authorities. Hence, the only way to demonstrate its efficacy and safety is by testing on humans. Therefore, clinical studies are essential to the development of new drugs and treatments. This is why many clinical trials volunteers get involved in the hope they can help other people. If you wish to become a clinical trial volunteer, here is a 4-steps way to joining a clinical trial.

Clinical trials are necessary to determine approval or not of a new drug onto the market

First step – Are you healthy or do you have a specific disease or illness
First thing you need to know: you can be a healthy volunteer, which mean you do not have to be ill in order to join a clinical trial. There are 4 phases in a clinical trial, called Phase I, Phase II, Phase III, Phase IV. Phase I of clinical trials usually involve testing the new medication on healthy volunteers to study its safety on human use. Phase I typically tests for changes in blood work, changes in vital signs, changes in electrocardiograms, short term side effects and any other reactions that can be linked to the investigational drug. Because of the unknown reactions or side effects of the new drugs, Phase I clinical studies tend to compensate generously people who volunteer. Phase II and Phase III of clinical trials generally involve patients (with the targeted disease or illness). During Phase II and III, more safety data are collected, but other goals, such as studying the efficacy of the new drug, how they work in human, the best dosage and way to administer it, its excretion, etc. Phase IV are “post-approval” studies. After their approval by the FDA, pharmaceutical or biotech companies often do phase IV studies in order to collect more information on a larger cohort.

Second step – Determine the clinical trials that suits you
Unlike many believe, chances are that there will be a clinical trial that will suit you. Clinical trial volunteers are welcomed in many fields : migraines, sinusitis, allergies, leukemia, obesity, etc. There are studies for almost every condition that needs a treatment.

Third step – Finding and joining a clinical trial
Many resources are available for you to find a clinical trial. The best place is to start here, on the internet. Several websites offer good directories of centers that run clinical trials, or the active studies. They also allow you to specifically search for an illness, such as migraines or allergies.

Fourth step : Joining a clinical trial: eligibility
When you find a study of interest, make sure you read the eligibility criteria. Is the clinical trial you are looking at enrolling only healthy clinical trial volunteers, or are they only looking for sick patients. Are they looking for men only, or women only? What is the age group they are targeting. Are there other criteria, such as smoking, history of other diseases. Look for the `Contacts` to find where the studies are being conducted and contact information of the center running the clinical trial, or to ask any other relevant question.
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What else do you need to know?

Will the sponsor pay for your travel if you are coming from far away (another city or state) to volunteer.

Make sure you read the consent form carefully and ask the staff to explain all the procedures that will occur during the trial, to avoid any surprise

Know your rights. As a volunteer, you always have the right to withdraw consent from the trial, this at all time. Although, you do not have to give an explanation when withdrawing consent, is it always better to inform the sponsor of your reasons behind it, so they can document it and readjust their goals and next studies if needed. Also, both sponsors and health authorities need to know if there were any abuse or bad treatment from the center conducting the trial.

Complete Directory

The use of clinical trials software can reduce the amount of work needed in a clinical trial by effectively helping different aspects such as data reporting, data analysis or data management. Moreover, clinical trials software can help in patient enrollment and recruitment. Here is a list of the available clinical trial management software available for you.

Advanced Clinical Software – StudyManager SE for Mid-size clinical trials
An enterprise-class web-based solutions designed to make the management of clinical trials faster, easier, and less expensive.

Akaza Research – OpenClinica for Large size clinical trials
Free, open source, web-based electronic data capture (EDC) system for clinical research.

Almac Clinical Technologies – iDiary for Mid-to-Large size clinical trials
Web and telephone-enabled electronic data capture of patient reported outcomes.

Aris Global – Software Solutions for the Life Sciences Industry for Small-to-Mid-size clinical trials
Provides pharmacovigilance, drug safety software, clinical trials management, medical communications and regulatory software solutions.

Bio-Optronics – Clinical Conductor Site CTMS for Mid-size clinical trials
Handles all aspects of clinical trial management for investigator sites, from patient databases, recruitment, visits, and more.

ChemWare – HORIZON LIMS for Mid–to-Large size clinical trials
For automating environmental, public health, clinical/toxicology, utility, process control and related laboratories.

Clinical Force – Clinical Force for CROs and Sponsors for Small-to-Mid-size clinical trials
Broad, flexible and modular CTMS solution delivered to small to mid sized sponsors or CROs.

Clinical Systems – CTMS for Small-to-Large size clinical trials
A great tool that assists organizations to collect Trial specific data to track study performance, schedule, monitor, and more.

Clinipace – Tempo for Mid-size clinical trials
Study management for post-approval research and registries conducted by biopharmaceutical companies, and research organizations.

ClinPhone – TrialWorks for Mid-size clinical trials
Powerful, user-friendly database designed specifically for day-to-day tracking and reporting of clinical and regulatory information.

ClinPlus – Clinical Trials Management for Small-to-Large size clinical trials
A suite of products offering robust solutions designed to help your team expedite clinical trials.

eClinForce – SmartStudy for Small-to-Large size clinical trials
Integrates comprehensive functionalities needed in the clinical trials process into a single, open web platform.

Elashoff Consulting – Patient Profiles for Mid-size clinical trials
Clinicians can view live clinical trial patient data in real-time, in a colorful, graphical presentation on their own desktop computer.

eResearchTechnology – EXPeRT eClinical for Mid-size clinical trials
Enable researchers to collect, interpret and distribute cardiac safety and clinical data accurately and efficiently.

Geospiza – Finch Suite for Mid-to-Large size clinical trials
Web based LIS platform enabling automated sequencing genotyping in a molecular diagnostic, clinical research environment.

InferMed – MACRO for Mid-to-Large size clinical trials
Electronic Data Collection for all trials, from Phase I through IV, scaling from a single site to large international trials.

MedNet – Study Management Tools for Mid-size clinical trials
Keep each site on track, whilst providing the online, real-time tools that Investigators and Research Coordinators need.

Nextrials – Prism for Mid-size clinical trials
Electronic Data Capture (EDC) solution streamlines the initiation and management of clinical trials.

Open Text – Livelink ECM – Clinicals for Small-to-Mid-size clinical trials
A comprehensive end-to-end clinical trials management solution for pharmaceutical and life sciences organizations.

PDA Cortex – PDA Cortex for for Mid-size clinical trials
Data capture and retrieval using a PDA by physicians, nurses and healthcare professionals, are enhancing patient care and efficiency.

Phase Forward – Clintrial for Mid-size clinical trials
Streamlines paper-based clinical data entry, and provides real-time data access and enhanced data quality.

Phoenix Data Systems – PDS for Small-to-Large size clinical trials
A combination of electronic data capture, interactive voice response, reporting, and data management to run well-managed studies.

Progeny Software – Progeny Clinical for Small-size clinical trials
The ideal clinical data management software to track family history data. Customize as many database fields as you want.

QlikTech – Life Sciences and Healthcare for Small-size clinical trials
QlikView puts information at your fingertips and frees you to make quick decisions, giving you intelligence you need to act faster.

Quadratek Data Solutions – clincase for Mid-size clinical trials
Complete software solution for EDC and CDM, ideally suited for integration with existing clinical trial processes and infrastructures

SigmaSoft International – DMSys for Mid-size clinical trials
Data management software for clinical trials that is based on GCP and regulatory compliance, user friendliness, and affordability.

SyMetric Sciences – SyMetric for Mid-size clinical trials
A comprehensive clinical data management system for clinical trial data collection.

TranSenda – Clinical Trial Manager for Small-size clinical trials
For emerging sponsors, biotech’s and CROs who want to move beyond spreadsheets and are not yet ready for large pharmaceutical software.

TrialStat! – ClinicalAnalytics for Mid-size clinical trials
Enables clinical research professionals to collect and manage study data nearly twice as fast as the industry average.

Winchester Business Systems – Protocol Manager for Small-size clinical trials
Helps clinical operations manage global trials of drugs, devices, biologics, and vaccines in all phases of development.

The Advantages

The use of clinical trial software will improve efficiency of clinical trials data management, for both small and large studies.

More and more biotechnology, pharmaceutical, and medical device companies as well as research organizations are learning about the advantages of using clinical trial software. This is because data management software will help in many phases of a study. As a matter of fact, those data management software are polyvant: they can assist in aspects from enrollment of patients or volunteers into the study to archiving of completed studies. Also, the use of those software can be beneficial in smaller studies (such as Phase I – with only a few volunteers) or in largers studies (such as Phase III studies – with thousands of participants).

Advantages of using data management software in clinical trials:

1. Allow to reduce the overall duration of clinical trials and cut down on their costs, but this without affecting the quality of the studies

- With today’s economy and the increasing cost of drug development, there is a need to cut down the cost of studies. Using clinical trial software will help create a better and more realistic budget for the studies, reduce the costs, improve productivity by reducing the amount of time needed to complete the studies.

2. Allow consistency by ensuring compliance with HIPAA, FDA or European regulatory guidelines, GCP, 21 CFR Part 11.

- Clinical trial software include major requirements.

3. Allow to invest the effort on the key elements : research and not management

- Regulatory requirements for clinical trials change constently. Clinical trial software are always up-to-date, therefore ease compliance with regulatory guidelines.

4. Facilitate recruitment of patients and volunteers, and important time points throughout the study

- Clinical trial software can be used to facilitate recruitment, screening, scheduling and follow up of patients or volunteers. They also help in being more rigorous with study requirements regarding physicians, institutions, staff qualification and possible difficulties.

Important things to remember:

• Just like any other computer program, it takes time to implement a computer software. It also takes time to learn how to use it. So before computerizing all your work or switching to a new program, make sure someone in your team is properly trained in using the software.

• Update and refresh your knowledge with online training.

• Many clinical trial software can be use remotely. Hence, you do not have to work on a desktop computer.

• Many data management software will allow you to personalize your trials, and to set up templates that can be used from trials to trials

• Security features allow protection of data. The system administrator can set access privileges to specific users and studies.

• Some clinical trial software can work with other programs (such as Microsoft Excel or other databases) and integrate them.

• Some software system give you the feature to notify you on the status of all ongoing studies, and this, on a single window.