The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Workplace collaboration requires a willingness to find solutions to problems, together with others. Which means that any successful collaborative vendor teaming effort requires a cooperative spirit and mutual respect, between individuals, within and between organizations for better oncology trial results.
Those most effective at building trust are able to understand a variety of perspectives, manage priorities from everyone on the team, and then decisively meet expectations as a reliable team player.
No more so is this inter-organizational collaboration needed than in the field of oncology clinical research, where multiple vendors must come together with the research Sponsor to successfully meet both their corporate and program objectives.
In this field advancements only occur if people join forces to defeat the disease.
Better teamwork benefits the whole.
Collaboration seems easy enough, we all collaborate daily in almost every aspect of our lives and work. However, we are also all very familiar with how quickly and easily misunderstandings between collaborators can become a real distraction from project goals.
Collaboration means paying attention to verbal and nonverbal cues, and then learning how to speak directly to the issue and address the challenge at hand. Communication, emotional Intelligence, analytical, problem solving, critical thinking, and respect for diversity are all broad skill areas essential to one’s collaboration skills toolkit.
In addition to this is the ability to: analyze problems without assigning blame; accurately assess the strengths and weaknesses of team members; brainstorm; compromise; respond to constructive criticism; identify obstacles to success; manage resources; and lighten up when appropriate with a sense of humor!
Elements of Successful Collaborative Vendor Teaming
- Partner roles in the collaborative process are clearly defined, agreed upon, and communicated;
- Open communication between partners means no info necessary to carry out tasks is withheld;
- Project goals always remain at the forefront – collaboration isn’t about individual gain;
- Carefully identify obstacles and address problems cooperatively as they occur;
- Teamwork is essential at all times;
- Reach consensus about task completion and other important items;
- Give credit where credit is due for contributions of all collaborators;
- Be willing to apologize for missteps and forgive others for mistakes. Holding a grudge or sabotaging the efforts of other team members destroys collaboration.
Successful collaboration methods tend to produce benefits such as faster turnaround times, more met deadlines and, as a result, less money spent. In addition, effective team collaboration enhances opportunities to share best practices, problem solve more efficiently, break down communication barriers and stay focused on the bigger picture of overall project outcomes.
Interestingly the most productive, innovative teams are those led by people who are both task- and relationship-oriented. What’s more, these ambidextrous leaders can readily change their style to meet the need of any particular situation that arises during a project.
Specialized Oncology CRO as Collaborative Vendor – Real World Evidence
An example of how an unwavering belief that cancer research will only advance if people join forces so that better teamwork benefits the whole is highlighted in the case study featured here.
- Mid-way into study startup the Sponsor discovered that institutional biosafety approvals were required in addition to the usual ethics approval.
- The majority of Sites selected globally for participation did not have existing Biosafety committees in place.
- Start-up delays of over 8 months were anticipated by the leading CRO for the trial.
Truly a potential nightmare for this single-compound biotech.
Collaboration to Overcome the Problem – Real World Evidence
The vendor partner that stepped-up to lead the charge in overcoming this challenge works with other CROs not as competitors but as collaborators for the greater purpose to achieve better oncology trial results.
Given its stable, experienced teamwork and skill in collaborative vendor teaming within the complex field of oncology clinical research this specialized oncology CRO was instrumental in getting biosafety committees up and running for this Sponsor by doing the following.
Worked collaboratively with the entire project team to develop a solution and corresponding action plan to attain the required institutional biosafety approval within a 3-month period for the region instead of the anticipated 8-month delay the leading CRO for the trial had anticipated.
Drafted study-specific biosafety procedures in compliance with applicable regulations and assisted each Site in the region to begin the process with a working draft instead of starting from scratch.
Shared tips and procedures from Sites more advanced in the biosafety committee process with Sites less advanced, to exponentially accelerate the process with results completed and already deemed acceptable.
Counselled other regions in the study supported by the Sponsor’s other CROs by participating in several team meetings to expedite the set-up of biosafety committees in those regions (Europe, USA) by sharing how-tos and lessons learned from successes at Canadian sites.
Real World Evidence – Real Results
Fueled by the unwavering belief that better teamwork benefits the whole, this specialized CRO jettisoned enrollment for this Sponsor’s oncology program to close 1 month early, and the program successfully advanced to Phase III.
Furthermore, many key Canadian Sites now have permanent in-house biosafety committees.
Your Specialized Oncology CRO – Scimega Research
With 20+ years unparalleled Canadian oncology experience Scimega Research joins forces with Sponsors and their vendor team to defeat cancer.
Scimega is a specialized oncology CRO that serves small to medium size biotech companies with its stable, experienced teamwork and skill in collaborative vendor teaming. We consistently deliver trial start-up times 50% faster than the North American average, premium quality data, and trial sites that are often among top enrollers in our Sponsors’ global oncology studies.
Contributed by: Julie Martin, Director, Clinical Operations