Whether you work for a site management organization or association management website or are a clinical research investigator, it will be beneficial to continue your education with clinical trials site management programs. Instead of relying on clinical trials management software or site management organization clinical research companies to supervise a research study, take a few courses that will enhance your skill set.

Additional training will not only increase your professional knowledge, but it will also ensure ease and accuracy in the research process. Consider the following alternatives before deciding what clinical drug trial site management education and training courses are right for you:

1. Enroll in clinical research site management educational programs.

2. Take part in individual educational courses focusing on site management in clinical research.

3. Register for a clinical trial site manager training course.

Action Steps
The best contacts and resources to help you get it done

Participate in clinical trial site management educational programs

Learn about site management in clinical trials through involved programs of study. Completing an educational or certificate program is advantageous for professionals starting out in the industry but is also beneficial for those investigators who have been working for awhile. Increased credentials and qualifications will set you apart from other individuals competing for or working in the same jobs.

I recommend: Learn about the clinical trials management program and strategic partnership between Global Research Services and the University of Rochester School of Nursing. Check out the Clinical Drug Trials Design and Management certificate program at the University of California, Santa Cruz.

Participate in individual clinical site management educational courses

Enroll in a single course to refresh your professional knowledge related to clinical trials data management and clinical trials site management basics and principles. If you do not feel you are in need of a full-service program of study, utilize individual classes to broaden your educational background and increase your expertise.

I recommend: Take a distance education course offered by the Pharmaceutical Education & Research Institute. Enroll in clinical trials management courses at the University of Chicago's Graham School of General Studies.

Participate in a site management in clinical trials training course

Take part in less institutional and structured clinical trial site management training courses or programs. Whether you require on-site training or would rather utilize the Internet, participating in additional training programs will allow you to do your job more efficiently as well as enhance your resume.

I recommend: View the training course offered by Barnett Educational Services. Take a look at Covance, a development services company providing training to clinical investigators.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  Be sure to keep all notes and documents pertaining to the management of clinical drug trial sites in a designated and labeled location so you can easily access the materials when you are planning or undertaking a clinical research trial. Reviewing what has and has not been successful will be beneficial to the flow of your new trial.

Sustain site management in clinical research by building up your supervisory resources. Manage comprehensive medical studies by investing in trial specific products. For instance, a thorough array of software for clinical trials data management exists for researchers who match the appropriate products with their investigative needs.

Oversee each facet of your clinical research site management study with industry-friendly products that anticipate your most pressing needs. For example, empower your investigative team with a pre-set backup plan that puts key players in place within 24 hours of receiving your study protocol and financial information. In addition, track adverse events with software designed to monitor such incidents. Furthermore, facilitate collaboration in your clinical drug trial site management team with integrated software programs. Contemplate these ideas and consider the following recommendations:

1. Handle emergencies in your clinical site management team and track adverse events.

2. Use trial specific software for clinical site management of your medical study.

3. Present and integrate data across your site management organization teams.

Action Steps
The best contacts and resources to help you get it done

Put a ready-to-go backup plan in place and monitor adverse events in your clinical site management

Build flexibility into your study. Maintain the trial's integrity even when unexpected situations arise. Tap the support of an expedited investigation team by purchasing a rapid recruiting method. Additionally, record side effects and meet mandatory deadlines with medical trial specific mechanisms.

I recommend: Contact the Rapid Recruit program at SMO-USA, Inc. to take advantage of this emergency recruitment tool that enlists the help of an elite network of investigators dedicated to join your study within one day of receiving your financial plan and protocol. In addition, report adverse events with Empirica Trace, a web-based product provided by Phase Forward Incorporated. Capture and analyze side effects and satisfy deadlines with regulatory reporting with this progressive solution to manage adverse events.

Capitalize on software designed for site management in clinical trials

Use software that entails end-to-end solutions for managing your medical study. Oversee various aspects of your drug trial such as budgetary information, recruitment, data collection and patient tracking.

I recommend: Purchase the StudyManager CTMS at Advanced Clinical Software for start-to-finish solutions for clinical trial site management. In addition, buy trial specific software from etrials to collect data and manage strict study control procedures. The company also provides other valuable services such as medical coding and secure data hosting.

Host presentations and integrate data within your clinical site management teams

Invest in a web-based workspace that allows your management teams to work in partnership with one another. Host real-time presentations and use formats that include a one-to-one or one-to-many design. In addition, integrate data across the various facets of your clinical study with data combining applications.

I recommend: eRoom Real-Time Services by EMC Corporation offers users resources to facilitate meetings in real time, and to maximize collaboration and presentations. Incorporate this application to host live discussions with clinical trials management teams or one-to-many presentations across site management organizations. Additionally, buy SAS Enterprise Data Integration Server from SAS Institute Inc., to oversee data integration projects such as clinical trials site management studies.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  Compare and contrast different clinical trials management software before you buy to make sure you find the best product for your company's needs.

Clinical trial site management is a burgeoning field of study that is comprised of investigators who are responsible for assessing the effectiveness and safety of an already established medication or device as well as a new one. Investigators will seek out and sign up healthy volunteers in studies that are usually designed to compare one product or device with another. Because humans are involved, there are very strict protocols and processes built into these types of studies. There are considerable costs for a full series of clinical trials and so sponsors are usually either biotechnology or pharmaceutical companies. There are a myriad of unique terms associated with this profession for you to become familiar with if you are interested in a career in this field.

Action Steps
The best contacts and resources to help you get it done

Contract research organization

A contract research organization or CRO is also referred to as a clinical research organization. A CRO provides support to the pharmaceutical industry by offering a range of 'outsourced' services including clinical drug site trial management which can include selection or monitoring of investigations, design of protocols and evaluation of reports on studies.

I recommend: For a more comprehensive definition see drugdevelopment-technology.com.

Electronic submission gateway

Electronic submission gateway (ESG) is an entity that was designed and constructed to provide a central transmission point for sending information electronically to the FDA. Clinical drug trial site managers know how to navigate ESG standards.

I recommend: For a definition on ESG see GlobalNet Services. For an overview of the standards and the official website that outlines the ESG go to CDER.

ICH

ICH stands for the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use and is a project that assembles regulatory authorities and experts in the pharmaceutical industries from the United States, Europe and Japan to discuss the technical aspects of pharmaceutical product registration. Clinical drug trial managers understand the importance of this agency.

I recommend: The official website for ICH can be found at ich.org.

EMEA

EMEA is the European medicines agency and is responsible for the evaluation of medicinal products. Similar to the FDA in the United States, the agency was established to harmonize and coordinate the work of national medicine regulatory agencies in Europe. Clinical drug trial managers know how to work with the EMEA.

I recommend: For more information you can go to EMEA.

Pharmacovigilance

Pharmacovigilance is a science that detects, assesses, understands and prevents the adverse effects of medicines. It is comprised of researching, monitoring, collecting and assessing information from a wide variety of sources on the undesirable effects of medications. Clinical drug trial managers know that pharmacovigilance is absolutely necessary.

I recommend: For more specifics on what pharmacovigilance entails you can check out RTI Health Solutions.

Data mining

Data mining is the process of taking data and analyzing it for hidden patterns so that more concise information can be extracted and used for decision making. Clinical drug trial managers mine data as part of their routine tasks.

I recommend: UCLA Anderson School of Management has a great overview and examples of data mining.